Krystal Biotech（KRYS）株式概要クリスタル・バイオテック社は、商業段階のバイオテクノロジー企業で、米国でアンメット・メディカル・ニーズの高い疾患を治療する遺伝子医薬品の発見、開発、製造、商業化を手がけている。 詳細KRYS ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長6/6過去の実績5/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より62.6%で取引されている 収益は年間36.48%増加すると予測されています 過去1年間で収益は81.5%増加しました リスク分析リスクチェックの結果、KRYS 、リスクは検出されなかった。すべてのリスクチェックを見るKRYS Community Fair Values Create NarrativeSee what 63 others think this stock is worth. Follow their fair value or set your own to get alerts.Analyst Price TargetsAN4.1% undervaluedAnalystConsensusTarget•19d agoKRYS: Global Expansion And Pipeline Shifts Will Shape Near-Term Performance294024AN25.3% overvaluedAnalystLowTarget•1mo agoUncertain Gene Therapy Dynamics Will Fuel Challenges Yet Spark Hope3003AN18.6% undervaluedAnalystHighTarget•1mo agoAging Populations And AI Will Accelerate Gene Therapy Adoption1601Top Analyst NarrativesAN4.1% undervaluedAnalystConsensusTarget•19d agoKRYS: Global Expansion And Pipeline Shifts Will Shape Near-Term Performance294024AN25.3% overvaluedAnalystLowTarget•1mo agoUncertain Gene Therapy Dynamics Will Fuel Challenges Yet Spark Hope3003AN18.6% undervaluedAnalystHighTarget•1mo agoAging Populations And AI Will Accelerate Gene Therapy Adoption1601View all narrativesKrystal Biotech, Inc. 競合他社TG TherapeuticsSymbol: NasdaqCM:TGTXMarket cap: US$5.6bAscendis PharmaSymbol: NasdaqGS:ASNDMarket cap: US$14.8bHalozyme TherapeuticsSymbol: NasdaqGS:HALOMarket cap: US$8.2bBioMarin PharmaceuticalSymbol: NasdaqGS:BMRNMarket cap: US$9.6b価格と性能株価の高値、安値、推移の概要Krystal Biotech過去の株価現在の株価US$302.0552週高値US$319.4852週安値US$122.80ベータ0.491ヶ月の変化9.24%3ヶ月変化14.99%1年変化138.44%3年間の変化154.83%5年間の変化354.48%IPOからの変化2,738.82%最新ニュースお知らせ • May 20Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.ライブニュース • May 17Krystal Biotech Gains UK Approval for Vyjuvek in Rare Skin Disorder TreatmentKrystal Biotech received approval from the UK Medicines and Healthcare products Regulatory Agency on May 15, 2026, for Vyjuvek, its wound treatment for dystrophic epidermolysis bullosa (DEB). Vyjuvek targets patients with DEB, a rare genetic disorder with limited treatment options, addressing an area of high medical need. This approval adds a new product to Krystal Biotech's portfolio and positions the company more clearly in rare disease therapies. The MHRA decision gives Krystal Biotech regulatory validation for its approach to treating DEB and opens access to patients in the UK health system. Investors may want to watch how quickly the company can translate this approval into uptake, reimbursement agreements and the generation of real-world data in a rare-disease setting.分析記事 • May 13There May Be Underlying Issues With The Quality Of Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc. ( NASDAQ:KRYS ) just reported some strong earnings, and the market reacted accordingly with a...Seeking Alpha • May 06Krystal Biotech: A Q1 Earnings Beat With Multiple Catalysts In 2026 And 2027Summary Krystal Biotech delivered strong Q1 2026 results, with Vyjuvek sales up 32% YoY to $116.4M and gross margin expanding to 95%. KRYS's robust balance sheet ($823M cash and negligible debt) and disciplined capital allocation fund a broad clinical pipeline without dilution risk. Two registrational readouts in 2026 and two more enrolling in 2027, position KRYS for significant pipeline-driven upside beyond Vyjuvek. I reiterate a Strong Buy rating, citing expanding TAM, platform validation, and continued operational outperformance. Read the full article on Seeking AlphaReported Earnings • May 05First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 46% per year, which means it is significantly lagging earnings growth.ナラティブの更新 • May 01KRYS: Future Returns Will Reflect Lung Cancer RMAT Milestone And Oncology Pipeline ExecutionAnalysts have raised their average price target on Krystal Biotech from $291 to $315. This reflects updated models that incorporate Vyjuvek sales assumptions, FY25 financials, and progress across multiple registrational programs following the latest Q4 report and management meetings.最新情報をもっと見るRecent updatesお知らせ • May 20Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.ライブニュース • May 17Krystal Biotech Gains UK Approval for Vyjuvek in Rare Skin Disorder TreatmentKrystal Biotech received approval from the UK Medicines and Healthcare products Regulatory Agency on May 15, 2026, for Vyjuvek, its wound treatment for dystrophic epidermolysis bullosa (DEB). Vyjuvek targets patients with DEB, a rare genetic disorder with limited treatment options, addressing an area of high medical need. This approval adds a new product to Krystal Biotech's portfolio and positions the company more clearly in rare disease therapies. The MHRA decision gives Krystal Biotech regulatory validation for its approach to treating DEB and opens access to patients in the UK health system. Investors may want to watch how quickly the company can translate this approval into uptake, reimbursement agreements and the generation of real-world data in a rare-disease setting.分析記事 • May 13There May Be Underlying Issues With The Quality Of Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc. ( NASDAQ:KRYS ) just reported some strong earnings, and the market reacted accordingly with a...Seeking Alpha • May 06Krystal Biotech: A Q1 Earnings Beat With Multiple Catalysts In 2026 And 2027Summary Krystal Biotech delivered strong Q1 2026 results, with Vyjuvek sales up 32% YoY to $116.4M and gross margin expanding to 95%. KRYS's robust balance sheet ($823M cash and negligible debt) and disciplined capital allocation fund a broad clinical pipeline without dilution risk. Two registrational readouts in 2026 and two more enrolling in 2027, position KRYS for significant pipeline-driven upside beyond Vyjuvek. I reiterate a Strong Buy rating, citing expanding TAM, platform validation, and continued operational outperformance. Read the full article on Seeking AlphaReported Earnings • May 05First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 46% per year, which means it is significantly lagging earnings growth.ナラティブの更新 • May 01KRYS: Future Returns Will Reflect Lung Cancer RMAT Milestone And Oncology Pipeline ExecutionAnalysts have raised their average price target on Krystal Biotech from $291 to $315. This reflects updated models that incorporate Vyjuvek sales assumptions, FY25 financials, and progress across multiple registrational programs following the latest Q4 report and management meetings.お知らせ • Apr 24Krystal Biotech, Inc. to Report Q1, 2026 Results on May 04, 2026Krystal Biotech, Inc. announced that they will report Q1, 2026 results Pre-Market on May 04, 2026ナラティブの更新 • Apr 17KRYS: Oncology Immunotherapy RMAT And Respiratory Programs Will Test Rare Disease OptimismAnalysts have lifted their average price target on Krystal Biotech by $7, reflecting updates to models around Vyjuvek sales expectations, FY25 financials, and the advancing pipeline, while incorporating a slightly higher discount rate and modestly revised revenue growth, profit margin, and P/E assumptions. Analyst Commentary Recent Street research on Krystal Biotech shows a wide spread of opinion, with several firms lifting price targets following the latest quarterly report and updated models for Vyjuvek and the broader pipeline.お知らせ • Apr 07Krystal Biotech, Inc., Annual General Meeting, May 15, 2026Krystal Biotech, Inc., Annual General Meeting, May 15, 2026.Board Change • Apr 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Catherine Mazzacco was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.ナラティブの更新 • Apr 01KRYS: Future CF And Ophthalmology Readouts Will Drive Long Term UpsideKrystal Biotech's analyst price target is maintained at $371, with analysts pointing to refined revenue growth and margin assumptions, along with Q4-driven updates to Vyjuvek forecasts and the broader pipeline, as key supports for the current valuation framework. Analyst Commentary Bullish analysts have been steadily revisiting their models on Krystal Biotech following recent updates on Vyjuvek, the broader pipeline, and Q4 results.ナラティブの更新 • Mar 18KRYS: Future CF And Ophthalmology Readouts Will Shape Long Term UpsideNarrative Update on Krystal Biotech The analyst fair value estimate for Krystal Biotech has shifted from $336 to $371, with the change largely tied to higher Vyjuvek sales assumptions, updated FY25 forecasts, and continued progress across multiple registrational and pivotal pipeline programs cited in recent research updates. Analyst Commentary Recent research updates on Krystal Biotech point to a cluster of upward price target revisions, with bullish analysts citing refreshed financial models, Vyjuvek launch assumptions, and advancing clinical programs across multiple indications as key inputs.ナラティブの更新 • Mar 04KRYS: Rising Oncology And Respiratory Pipeline Expectations May Test Rare Disease OptimismThe analyst price target for Krystal Biotech has been raised from $202 to $241, with analysts pointing to updated models that reflect higher Vyjuvek sales assumptions, refined FY25 financials, and advancing registrational trials across multiple programs. Analyst Commentary Recent Street research on Krystal Biotech highlights a series of upward price target revisions clustered around the latest quarterly update, Vyjuvek launch assumptions, and progress across the pipeline.Price Target Changed • Feb 25Price target increased by 8.3% to US$313Up from US$289, the current price target is an average from 9 analysts. New target price is 17% above last closing price of US$267. Stock is up 47% over the past year. The company is forecast to post earnings per share of US$7.84 for next year compared to US$7.08 last year.Recent Insider Transactions Derivative • Feb 20Independent Director notifies of intention to sell stockDino Rossi intends to sell 19k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of February. If the sale is conducted around the recent share price of US$261, it would amount to US$5.0m. Since March 2025, Dino has owned 78.69k shares directly. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.ナラティブの更新 • Feb 18KRYS: Future Returns Will Reflect Vyjuvek Penetration And CF And Oncology Pipeline ExecutionNarrative Update: Krystal Biotech Analyst Price Target Shift The analyst price target for Krystal Biotech has been revised higher from $273.60 to $291.22, with analysts pointing to recent model updates that reflect Vyjuvek demand trends, advancing ophthalmology programs, and early data from the broader pipeline. Analyst Commentary Recent Street research on Krystal Biotech points to a cluster of upward price target revisions, with most commentary tying those changes to product traction for Vyjuvek, the maturing ophthalmology pipeline, and early data in cystic fibrosis and other programs.Reported Earnings • Feb 18Full year 2025 earnings: Revenues and EPS in line with analyst expectationsFull year 2025 results: EPS: US$7.08 (up from US$3.12 in FY 2024). Revenue: US$389.1m (up 34% from FY 2024). Net income: US$204.8m (up 130% from FY 2024). Profit margin: 53% (up from 31% in FY 2024). The increase in margin was primarily driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) were also in line with analyst expectations. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth.新しいナラティブ • Feb 16The Rare Disease Rocket ShipKrystal Biotech reports tomorrow, February 17, 2026. The narrative is no longer about survival; it’s about dominance.Recent Insider Transactions Derivative • Feb 10Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 13k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of February. If the sale is conducted around the recent share price of US$277, it would amount to US$3.5m. Since March 2025, Kathryn has owned 19.32k shares directly. Company insiders have collectively sold US$7.5m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Feb 10+ 1 more updateKrystal Biotech, Inc. to Report Q4, 2025 Results on Feb 17, 2026Krystal Biotech, Inc. announced that they will report Q4, 2025 results Pre-Market on Feb 17, 2026ナラティブの更新 • Feb 04KRYS: Future CF Data Readouts May Redefine Long Term Upside PotentialAnalysts have increased their price target on Krystal Biotech from $252 to $336, citing updated models that factor in revised assumptions for revenue growth, profit margins, and future P/E multiples following recent clinical data and pipeline updates. Analyst Commentary Recent Street research on Krystal Biotech has centered on a series of higher price targets, with bullish analysts revisiting their models after clinical updates and product pipeline progress.ナラティブの更新 • Jan 21KRYS: Future Returns Will Reflect 96% Margins And Early CF Pipeline ProgressWe are raising our analyst price target on Krystal Biotech from $223 to $273.60. This reflects updated models that incorporate recent analyst work on Vyjuvek, early KB407 cystic fibrosis data, and revised assumptions for revenue growth, profit margin, and future P/E multiples.Valuation Update With 7 Day Price Move • Jan 13Investor sentiment improves as stock rises 17%After last week's 17% share price gain to US$292, the stock trades at a forward P/E ratio of 37x. Average trailing P/E is 21x in the Biotechs industry in the US. Total returns to shareholders of 262% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$560 per share.お知らせ • Jan 09Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 Coral-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic FibrosisKrystal Biotech, Inc. announced a positive interim clinical update from the highest dose cohort of CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407.Price Target Changed • Jan 09Price target increased by 9.3% to US$250Up from US$229, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$249. Stock is up 59% over the past year. The company is forecast to post earnings per share of US$6.74 for next year compared to US$3.12 last year.お知らせ • Jan 08Krystal Biotech to Announce Interim Clinical Update from Highest Dose Cohort of Phase 1 CORAL-1 Study Evaluating KB407 in Patients with Cystic FibrosisKrystal Biotech, Inc. announced that it will host an investor conference call and webcast on January 8, 2026, to disclose an interim clinical update from CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis. The interim clinical update will focus on results from patients in the highest dose cohort of CORAL-1 and include molecular assessments of KB407 transduction and wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein expression following inhaled administration of KB407.ナラティブの更新 • Jan 07KRYS: Elevated Expectations For Rare Disease Portfolio May Prove UnsustainableAnalysts have lifted their Krystal Biotech fair value estimate from US$176 to US$202, citing higher price targets from recent research, improving access to capital for biotech, and support from Vyjuvek revenue trends and gross margin performance. Analyst Commentary Recent Street research has generally framed Krystal Biotech within a more constructive backdrop for U.S. biotech, pointing to supportive data readouts, active dealmaking by larger peers, and what some describe as better access to capital.Price Target Changed • Dec 18Price target increased by 7.8% to US$229Up from US$213, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$236. Stock is up 51% over the past year. The company is forecast to post earnings per share of US$6.58 for next year compared to US$3.12 last year.ナラティブの更新 • Dec 15KRYS: Future Returns Will Reflect 96% Margins And Expanding International UptakeAnalysts have nudged their price target on Krystal Biotech higher to about $220, reflecting stronger than expected Vyjuvek revenue, early traction from the Germany launch, and exceptionally high gross margins that support the company’s long term profitability outlook. Analyst Commentary Bullish analysts point to the latest quarter as evidence that Krystal Biotech is executing ahead of expectations, with Vyjuvek demand and geographic expansion translating into faster top line growth and stronger earnings power than previously modeled.ナラティブの更新 • Dec 01KRYS: Future Results Will Reflect Margin Strength and International Launch PerformanceAnalysts have raised their price target for Krystal Biotech to $220, up from $216. They cite stronger-than-expected Vyjuvek revenue, international sales growth, and robust gross margins as key drivers behind the increased valuation.ナラティブの更新 • Nov 17KRYS: Future Momentum Will Depend on Gross Margin Strength and Pipeline ProgressAnalysts have increased Krystal Biotech’s price target from $212.50 to $223.00. They cite stronger-than-expected Vyjuvek revenue, expansion in Germany, and improved profit margins as key factors supporting the higher valuation.分析記事 • Nov 10Investors Shouldn't Be Too Comfortable With Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc.'s ( NASDAQ:KRYS ) robust earnings report didn't manage to move the market for its stock. Our...Major Estimate Revision • Nov 10Consensus EPS estimates increase by 19%The consensus outlook for earnings per share (EPS) in fiscal year 2025 has improved. 2025 revenue forecast increased from US$383.7m to US$388.8m. EPS estimate increased from US$5.08 to US$6.03 per share. Net income forecast to grow 23% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target up from US$213 to US$220. Share price was steady at US$198 over the past week.Reported Earnings • Nov 04Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$2.74 (up from US$0.95 in 3Q 2024). Revenue: US$97.8m (up 17% from 3Q 2024). Net income: US$79.4m (up 192% from 3Q 2024). Profit margin: 81% (up from 32% in 3Q 2024). The increase in margin was primarily driven by lower expenses. Revenue exceeded analyst estimates by 4.7%. Earnings per share (EPS) also surpassed analyst estimates by 145%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 114% per year but the company’s share price has only increased by 37% per year, which means it is significantly lagging earnings growth.ナラティブの更新 • Nov 01KRYS: Global Expansion And Pipeline Shifts Will Shape Near-Term PerformanceKrystal Biotech's average analyst price target has been revised downward, with a reduction of up to $10 per share. Analysts cite updated product prioritizations, mixed quarterly results, and cautious near-term revenue forecasts.お知らせ • Oct 21Krystal Biotech, Inc. to Report Q3, 2025 Results on Nov 03, 2025Krystal Biotech, Inc. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 03, 2025ナラティブの更新 • Oct 18Global Expansion And Clinical Readouts Will Unlock New MarketsThe analyst consensus price target for Krystal Biotech has increased from $205.20 to $212.50. This change reflects updated evaluations as analysts factor in new product development priorities and ongoing commercial performance.お知らせ • Oct 15Krystal Biotech, Inc. Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic KeratitisKrystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK). The FDA's platform technology designation program is intended to provide efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies. Potential benefits of the designation may include early and more frequent engagement with the FDA during clinical development as well as the opportunity to leverage manufacturing and nonclinical safety data from a prior product using the designated platform technology, such as VYJUVEK, in submissions to the FDA. The FDA may also consider previous inspectional findings related to the manufacture of a drug that incorporates the designated platform technology. To be eligible for a platform technology designation, a technology must be well-understanding and reproducible, used in an FDA-approved drug or biologic product, such as VYJ UVEK, have the potential to support the development of multiple drugs or biologic products without compromising quality, manufacturing, or safety, and have a reasonable likelihood to bring significant efficiencies to the development or manufacturing process as well as to the FDA review process. Drug product applications that are then recognized by the FDA to incorporate this technology may leverage the potential benefits of the designation. KB801 is a redosable eye drop gene treatment designed to enable sustained, localized expression and secretion of vein growth factor (NGF) by epithelial cells in the front of the eye for the treatment of NK, a rare,degenerative corneal disease that leads to corneal epithelial defects, ulcers, and perforation. Recombinant NGF eye drops have been shown to significantly improve corneal healing and are approved for the treatment of NK in multiple jurisdictions worldwide, but rapid clearance from the eye requires intensive administration six times a day, limiting therapeutic utility. By enabling the cells of the front of the eye to produce NGF locally, KB801 has the potential to significantly reduce the treatment burden for patients while also maintaining more consistent NGF levels in the front of the eye. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics.分析記事 • Oct 09Market Participants Recognise Krystal Biotech, Inc.'s (NASDAQ:KRYS) Earnings Pushing Shares 29% HigherThe Krystal Biotech, Inc. ( NASDAQ:KRYS ) share price has done very well over the last month, posting an excellent gain...お知らせ • Sep 16Krystal Biotech Announces FDA Approval of Updated VYJUVEK LabelKrystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK®? (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in the United States, as well as results from the open label extension study conducted in the United States and published earlier this year, which collectively reinforce the long-term safety and efficacy of VYJUVEK across patients of all ages, including in cases of patient or caregiver application. VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEk was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVE K is approved in the United States, Europe, and Japan. VYJUVE k gel may be applied by a healthcare provider, a caregiver, or the patient. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.ash hands and wear protective gloves when changing wound dressings. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics.Reported Earnings • Aug 04Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2025 results: EPS: US$1.33 (up from US$0.54 in 2Q 2024). Revenue: US$96.0m (up 37% from 2Q 2024). Net income: US$38.3m (up 146% from 2Q 2024). Profit margin: 40% (up from 22% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 4.4%. Earnings per share (EPS) also surpassed analyst estimates by 14%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.お知らせ • Jul 29Krystal Biotech, Inc. to Report Q2, 2025 Results on Aug 04, 2025Krystal Biotech, Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 04, 2025お知らせ • Jul 25Krystal Biotech Announces Approval of VYJUVEK by Japan's Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that on July 24, 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB), starting from birth. VYJUVEK is the first genetic medicine approved in Japan for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The Japanese approval allows for dosing at home or in a healthcare setting, with the option for administration by patients or their family members. As per the approval issued by the MHLW, VYJUveK is intended for use only in patients with a definite diagnosis of dystrophic epidermorysis bullosa. Genetic testing is not a requirement for treatment. VYJUVE K is the first genetic medicine approved In Japan for home administration after undergoing regulatory evaluation and environmental safety confirmation for type 1 use in accordance with the Cartagena Act. The timing for availability of VYJUVEK in Japan will depend on completion of reimbursement procedures currently underway. The Company currently expects to launch in Japan by the end of this year. The approval by Japan's MHLW was based on a comprehensive clinical dataset, which included results from an open label extension study conducted in Japanese patients. Results from the Japanese open label extension study closely mirrored prior clinical experience, including the Company's Phase 3 study in the United States, with all four patients that completed the study achieving the primary study endpoint of full wound closure at six months. VYJUVEk was also well tolerated and exhibited a safety profile in Japanese patients that was consistent with previous studies. The re- examination period for VYJUVEK In Japan is ten years. VYJUVEV was previously approved by the Food and Drug Administration in the United States in May 2023 and by the European Commission in April 2025. JAPAN INDICATION: Dystrophic epidermolytic bullosa.お知らせ • Jul 09Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of Kb801 for the Treatment of Neurotrophic KeratitisKrystal Biotech, Inc. announced that the first patient has been dosed in its Phase 1/2 clinical trial ("EMERALD-1"), a 2:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of neurotrophic keratitis (NK). KB801 is a redosable eye drop gene therapy in development for the treatment of NK, a degenerative corneal disease characterized by damage or loss of function in the neurons innervating the eye leading to corneal epithelial defects, ulcers, and perforation. Left untreated, NK can result in severe vision loss. Although NK is a rare disease with an estimated prevalence in the range of 10 to 50 cases per 100,000, claims data analyses suggest awareness and diagnosis rates are on the rise in the United States. Based on available claims data, an estimated 68,000 patients in the United States had a NK claim in 2024, up over 115% from 31,000 patients with a NK claim in 2020. EMERALD-1 is a randomized, double-masked, multicenter, placebo-controlled study evaluating KB801, administered as an eye drop, for the treatment of NK. Up to 27 adults with Stage 2 or Stage 3 NK, as defined by the Mackie criteria, will be enrolled and randomized 2:1 to receive either KB801, at a concentration of 1010 PFU/mL, or placebo topically to the study eye twice weekly for 8 weeks. The primary objective of EMERALD-1 is to evaluate the safety and tolerability of topical ocular administration of KB801 in patients with NK. The secondary objective is evaluation of efficacy based on the proportion of patients with complete durable healing of corneal epithelium at 8 weeks, defined as 0 mm corneal fluorescein staining in the area of the corneal lesion at both week 8 and 0 mm corneal fluorescein staining in the same area at week 10, as assessed by a masked reader. Additional exploratory efficacy measures will include change in corneal lesion size from baseline, each assessed at weeks 4, 6, 8, 10, and 20, as well as evaluations of corneal sensation and patient-reported symptom burden. More details of the EMERALD-1 study can be found at www.clinicaltrials.gov under NCT identifier NCT06999733.お知らせ • Jun 25Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of Kb803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the first patient has been dosed in its Phase 3 clinical trial ("IOLITE"), an intra-patient, double-blind, multicenter, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. KB803 is designed to deliver two copies of the COL7A1 transgene to the corneal epithelium and enable local type VII collagen production in the front of the eye. IOLITE is an intra- patient, double-blind, placebo-controlled, multicenter Phase 3 study with a crossover design to evaluate KB803, administered as an eye drop, for the treatment and prevention of Corneal abrasions in DEB patients, 6 months of age or older. Patients seeking to participate in IOLITE must first enroll in the ongoing natural history study and complete a 12-week run-in period, during which they report the number of days that they experience symptoms of corneal abrasions. Subjects meeting the inclusion criteria following the 12-week run-in are eligible to participate in the IOLITE trial. The goal of therapy with KB803 is to address the fundamental disease-causing mechanism at the molecular level, by providing the patient's epithelial cells of the eye with the template to make normal type VII collagen locally. In a DEB patient treated under compassionate use with clinical observations reported the New England Journal of Medicine, regular eye drop administration was well tolerated with full corneal healing observed at three months, as well as significant visual acuity improvement from hand motion to 20/25 by eight months.お知らせ • Jun 03Krystal Biotech Presents Phase 1/2 Clinical Trial Results for Inhaled KB707 in Lung Cancer at ASCO 2025On June 2, 2025, Krystal Biotech, Inc. provided a clinical update on the monotherapy cohort from its Phase 1/2 clinical trial of inhaled KB707 for the treatment of solid tumors of the lung, which was presented by Wen Wee Ma, MD, Enterprise Vice Chair, Research, Cancer Institute, Cleveland Clinic, in a poster entitled “Inhaled KB707, a Novel HSV-based Immunotherapy, as a Monotherapy in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs: Efficacy and Safety Results from a Phase 1/2 Study” at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.分析記事 • May 23Why We're Not Concerned Yet About Krystal Biotech, Inc.'s (NASDAQ:KRYS) 26% Share Price PlungeTo the annoyance of some shareholders, Krystal Biotech, Inc. ( NASDAQ:KRYS ) shares are down a considerable 26% in the...Reported Earnings • May 07First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst quarter 2025 results: EPS: US$1.24 (up from US$0.033 in 1Q 2024). Revenue: US$88.2m (up 95% from 1Q 2024). Net income: US$35.7m (up US$34.8m from 1Q 2024). Profit margin: 41% (up from 2.1% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 8.3%. Earnings per share (EPS) also missed analyst estimates by 12%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 102% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth.お知らせ • Apr 28Krystal Biotech Announces European Commission Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. VYJUveK is the first corrective medicine approved in Europe for the treatment of DEB. The approval granted by the EC allows for flexible VYJUVEK dosing either at home or in healthcare setting, with the option for patient or caregiver administration if deemed appropriate by a healthcare professional. The EC approval follows the positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in February and was based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company's open label extension study and real-world experience in the United States. VYJUVEk was approved by the FDA in the United States in May 2023 and is also under review for approval by Japan's Pharmaceuticals and Medical Devices Agency with a decision expected in 2H 2025. VYJUVE K is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patient from birth with dystrophic epider molysis bullosa with mutation(s) in the collagen type VII alpha1 chain (COL7A1).お知らせ • Apr 17Krystal Biotech, Inc. to Report Q1, 2025 Results on May 06, 2025Krystal Biotech, Inc. announced that they will report Q1, 2025 results Pre-Market on May 06, 2025お知らせ • Apr 04Krystal Biotech, Inc., Annual General Meeting, May 16, 2025Krystal Biotech, Inc., Annual General Meeting, May 16, 2025.Recent Insider Transactions Derivative • Mar 14Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of March. If the sale is conducted around the recent share price of US$178, it would amount to US$4.5m. For the year to December 2018, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • Mar 02Executive VP & Chief Accounting Officer exercised options and sold US$1.0m worth of stockOn the 28th of February, Kathryn Romano exercised options to acquire 6k shares at no cost and sold these for an average price of US$179 per share. This trade did not impact their existing holding. Since March 2024, Kathryn has owned 12.94k shares directly. Company insiders have collectively sold US$3.9m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Feb 28Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic EpidermolysisKrystal Biotech, Inc. welcomed the European Medicines Agency's (EMA's) announcement that its Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK® (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. The CHMP's positive opinion includes support for administration of VYJUVEK in either a health care setting (e.g., a clinic) or at home. If deemed appropriate by a healthcare professional, trained patients or caregivers may also apply VYJUVEK. The positive opinion issued by the CHMP is based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, published in Nature Medicine and the New England Journal of Medicine, respectively, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration. The long-term safety and efficacy of B-VEC is further supported by results from the Company's open label extension study completed in the United States as well as real-world experience with VYJUVEK since launching the United States in 2023.Valuation Update With 7 Day Price Move • Feb 26Investor sentiment improves as stock rises 16%After last week's 16% share price gain to US$181, the stock trades at a forward P/E ratio of 25x. Average trailing P/E is 17x in the Biotechs industry in the US. Total returns to shareholders of 182% over the past three years.Seeking Alpha • Feb 21Krystal Biotech Soars As Q4 Earnings Put Blockbuster Commercialization In FocusSummary Krystal Biotech's VYJUVEK shows strong growth, with 2025 sales expected to exceed $1B, bolstered by launches in the EU and Japan. Q4 earnings beat EPS expectations but slightly missed revenue forecasts; however, management's 2025 outlook coming catalysts drove a strong rally in shares. Key 2025 catalysts include VYJUVEK's EU and Japan launches, Phase 3 ocular DEB results, and progress in CF and lung gene therapy. KRYS stock remains a STRONG BUY with a $225/share 12-month target, driven by impressive growth and new market opportunities. Read the full article on Seeking AlphaReported Earnings • Feb 19Full year 2024 earnings: EPS exceeds analyst expectationsFull year 2024 results: EPS: US$3.12 (up from US$0.40 in FY 2023). Revenue: US$290.5m (up 473% from FY 2023). Net income: US$89.2m (up US$78.2m from FY 2023). Profit margin: 31% (up from 22% in FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 7.9%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 87% per year but the company’s share price has only increased by 45% per year, which means it is significantly lagging earnings growth.お知らせ • Feb 06Krystal Biotech, Inc. to Report Q4, 2024 Results on Feb 19, 2025Krystal Biotech, Inc. announced that they will report Q4, 2024 results Pre-Market on Feb 19, 2025お知らせ • Dec 19Krystal Biotech Announces Early Evidence of Monotherapy Activity in Heavily Pre-Treated Patients with Advanced Non-Small Cell Lung CancerKrystal Biotech, Inc. announced initial clinical results from its ongoing KYANITE-1 study evaluating inhaled KB707 in patients with solid tumors of the lung. KB707 administered via inhalation demonstrated early evidence of monotherapy activity that was most pronounced in patients with advanced non-small cell lung cancer (NSCLC), where an objective response rate (ORR) of 27% and disease control rate (DCR) of 73% were observed as of data cut-off on December 6, 2024. KYANITE-1 is an ongoing, open-label, multicenter, dose escalation and expansion study evaluating inhaled KB707 for the treatment of solid tumors of the lung. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient's tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation.Recent Insider Transactions Derivative • Dec 15Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of December. If the sale is conducted around the recent share price of US$173, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Dec 13Krystal Biotech, Inc. Announces Initial Clinical Update for Rare Respiratory Disease Programs KB408 and KB407Krystal Biotech, Inc. announced clinical data updates for both KB408 and KB407, the Company's clinical-stage, inhaled genetic medicine programs in Phase 1 for the treatment of rare respiratory diseases. Today's updates include molecular data from multiple patients demonstrating SERPINA1 delivery and alpha-1 antitrypsin (AAT) expression within the respiratory tract following KB408 administration as well as safety and tolerability data for both KB407 and KB408 that, taken together, highlight the potential of the Company's platform to safely deliver genetic cargo to the lung. KB408 for the treatment of alpha-1 antitryps in lung disease. KB408 is being evaluated in the Company's Phase 1 SERPENTINE-1 study. The Company expects to report data from Cohort 3 in 1H 2025, including data on CFTR gene delivery and expression in patients with cystic fibrosis. VYJUVEK®? is the Company's first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa.お知らせ • Dec 10Krystal Biotech Provides Update on EMA’s Ongoing Regulatory Review of B-VEC for Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company’s Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) that was scheduled for December 6, 2024, and asked the Company to submit written responses to the remaining outstanding issues. There are no Major Objections outstanding from the EMA with respect to the full approval of B-VEC. The Company now anticipates a CHMP opinion in First Quarter 2025 while the launch timelines remain unchanged with a commercial launch in Germany still planned for Second Quarter 2025. About Dystrophic Epidermolysis Bullosa (DEB) DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal. About B-VEC and VYJUVEK B-VEC is a non-invasive, redosable gene therapy built to deliver two copies of the COL7A1 gene to treat DEB at the molecular level by providing the patient’s cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. B-VEC was approved by U.S. Food and Drug Agency (FDA) in May 2023 for the treatment of DEB and is marketed and sold in the U.S. under the name VYJUVEK®.お知らせ • Oct 28Krystal Biotech, Inc. to Report Q3, 2024 Results on Nov 04, 2024Krystal Biotech, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 04, 2024Seeking Alpha • Oct 14Krystal Biotech: Q4 Catalysts Expected With VYJUVEK Revenue Growth Pressing OnSummary The company anticipates significant Q4 2024 data releases for KB707 in solid tumors and KB408 in AATD lung disease, potentially boosting shareholder value. Jeune Therapeutics, a subsidiary, shows promise in aesthetics with positive phase 1 data, changing the treatment paradigm in the aesthetics market space. VYJUVEK, approved for DEB, saw a 55.3% revenue increase in Q2 2024, with potential European expansion pending MAA approval. Financially stable with $628.9M cash, but may need additional funding within 12 months; has a $150M ATM agreement with Cowen & Co. LLC. in place if necessary. Read the full article on Seeking AlphaRecent Insider Transactions Derivative • Sep 15Founder notifies of intention to sell stockSuma Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of September. If the sale is conducted around the recent share price of US$199, it would amount to US$5.0m. Since December 2023, Suma's direct individual holding has decreased from 1.66m shares to 1.62m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.新しいナラティブ • Aug 29Expanding Global Reach With VYJUVEK Set To Skyrocket Revenue And Sharpen Market Edge International expansion and upcoming product launches indicate significant potential for revenue growth and market diversification.Price Target Changed • Aug 28Price target increased by 7.5% to US$204Up from US$190, the current price target is an average from 9 analysts. New target price is approximately in line with last closing price of US$204. Stock is up 60% over the past year. The company is forecast to post earnings per share of US$2.59 for next year compared to US$0.40 last year.Major Estimate Revision • Aug 05Consensus revenue estimates increase by 11%The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$269.1m to US$299.6m. EPS estimate increased from US$2.33 to US$2.67 per share. Net income forecast to grow 72% next year vs 9.7% decline forecast for Biotechs industry in the US. Consensus price target of US$193 unchanged from last update. Share price fell 12% to US$181 over the past week.Seeking Alpha • Jul 31Krystal Biotech: High Valuation Merits Caution Ahead Of Q2 Earnings (Rating Downgrade)Summary Krystal Biotech's Q1 2024 revenue increased to $45.25 million but fell short of analyst expectations of $47.37 million. Analysts expect Q2 earnings to be $65.49 million. Vyjuvek's patient adherence rate dropped slightly to 91% in Q1 from 96% in the previous quarter. Krystal's pipeline, beyond dermatological and aesthetic pursuits, is pretty speculative and pursuing highly contested indications. I recommend a rating downgrade "hold" for Krystal due to its high valuation. Read the full article on Seeking Alphaお知らせ • Jul 26Krystal Biotech, Inc. to Report Q2, 2024 Results on Aug 05, 2024Krystal Biotech, Inc. announced that they will report Q2, 2024 results Pre-Market on Aug 05, 2024Recent Insider Transactions Derivative • Jun 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of June. If the sale is conducted around the recent share price of US$177, it would amount to US$4.4m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2023, Krish's direct individual holding has decreased from 1.66m shares to 1.61m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • May 22Independent Director notifies of intention to sell stockJulian Gangolli intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of May. If the sale is conducted around the recent share price of US$164, it would amount to US$3.3m. Since March 2024, Julian has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$17m more than they bought, via options and on-market transactions in the last 12 months.Major Estimate Revision • May 13Consensus EPS estimates increase by 16%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$260.0m to US$268.7m. EPS estimate increased from US$1.90 to US$2.20 per share. Net income forecast to grow 52% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price was steady at US$155 over the past week.お知らせ • Apr 28Krystal Biotech, Inc. to Report Q1, 2024 Results on May 06, 2024Krystal Biotech, Inc. announced that they will report Q1, 2024 results at 9:30 AM, US Eastern Standard Time on May 06, 2024お知らせ • Apr 23Krystal Biotech, Inc Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the LungKrystal Biotech, Inc. announced that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung, for the treatment of patients with locally advanced or metastatic solid tumors of the lung. The KYANITE-1 clinical trial is an open-label, multicenter, dose escalation and expansion study to evaluate inhaled KB707 monotherapy in patients with advanced solid tumor malignancies affecting the lungs. Details of the KYANITE-1 study can be found at www.clinicaltrials.gov under NCT identifier: NCT06228326. In February 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. This is the second Fast Track Designation for the KB707 program. In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-PD-1 relapsed/refractory locally advanced or metastatic melanoma. IL-2 and IL-12 are secreted cytokines with complementary functions promoting cell-mediated immunity in humans. Both IL-2 and IL-12 have been shown to elicit anti-tumor immune responses in preclinical models and in clinical settings and have been extensively studied for their potential in cancer immunotherapy. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient’s tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation.Major Estimate Revision • Apr 16Consensus EPS estimates increase by 11%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$254.7m to US$261.7m. EPS estimate increased from US$1.75 to US$1.95 per share. Net income forecast to grow 395% next year vs 9.2% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price fell 5.4% to US$170 over the past week.お知らせ • Apr 05Krystal Biotech, Inc., Annual General Meeting, May 17, 2024Krystal Biotech, Inc., Annual General Meeting, May 17, 2024, at 16:00 US Eastern Standard Time. Agenda: To elect the three Class I director nominees named in the Proxy Statement; to ratify the appointment of KPMG LLP as company's independent registered public accounting firm for company's fiscal year ending December 31, 2024; to consider and act upon a non-binding, advisory vote on the compensation of company's named executive officers; and to transact such other business as may properly come before the Annual Meeting or any adjournment(s) or postponement(s) of the Annual Meeting.Recent Insider Transactions Derivative • Mar 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of March. If the sale is conducted around the recent share price of US$172, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Krish's direct individual holding has decreased from 1.73m shares to 1.64m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • Feb 28Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of February. If the sale is conducted around the recent share price of US$111, it would amount to US$900k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.Seeking Alpha • Feb 28Krystal Biotech's Future Brightens With Vyjuvek's Robust LaunchSummary Vyjuvek's Successful Launch: Q4 earnings show strong sales and high patient compliance for Vyjuvek, Krystal Biotech's DEB treatment. Financial Health: The Company boasts a robust balance sheet with significant cash reserves, suggesting a low likelihood of near-term financing needs. Market Sentiment: Despite mixed stock performance, strong institutional ownership and projected revenue growth signal positive market sentiment. Investment Recommendation: KRYS remains a "Strong Buy," with Vyjuvek's success bolstering confidence in the company's future prospects. Read the full article on Seeking AlphaPrice Target Changed • Feb 27Price target increased by 14% to US$176Up from US$154, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$170. Stock is up 108% over the past year. The company is forecast to post earnings per share of US$1.46 for next year compared to US$0.40 last year.New Risk • Feb 27New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (57% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (9.8% increase in shares outstanding).Breakeven Date Change • Feb 26Forecast breakeven date moved forward to 2024The 8 analysts covering Krystal Biotech previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$115.0m in 2024. Average annual earnings growth of 46% is required to achieve expected profit on schedule.お知らせ • Feb 21Krystal Biotech, Inc. to Report Q4, 2023 Results on Feb 26, 2024Krystal Biotech, Inc. announced that they will report Q4, 2023 results Pre-Market on Feb 26, 2024Seeking Alpha • Feb 20Krystal Biotech: Ready For LaunchSummary Krystal Biotech, Inc. has gained 50% in the past year after receiving FDA approval for its gene therapy to treat dystrophic epidermolysis bullosa. The company's pipeline also includes early-stage treatments for oncology and cystic fibrosis, with some key early-stage trial milestones expected by 2024. Analysts have given positive ratings to the stock, with price targets ranging from $139 to $180 per share. The company ended Q3 with nearly $600 million in cash and marketable securities. What is ahead for Krystal Biotech in the quarters ahead is highlighted in the paragraphs below. Read the full article on Seeking AlphaRecent Insider Transactions Derivative • Jan 24Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 3k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of January. If the sale is conducted around the recent share price of US$130, it would amount to US$325k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Jan 05Krystal Biotech Receives Permanent J-Code (J3401) for VYJUVEK®Krystal Biotech, Inc. announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code for VYJUVEK became effective on January 1, 2024. J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional. J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing. VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.Recent Insider Transactions Derivative • Dec 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of December. If the sale is conducted around the recent share price of US$107, it would amount to US$2.7m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2022, Krish's direct individual holding has decreased from 1.78m shares to 1.66m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Nov 29Krystal Biotech Announces EMA Validation of Marketing Authorization Application for Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the Company's Marketing Authorization Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024. In September 2023, Krystal Biotech received a positive opinion from the EMA Pediatric Committee on the Pediatric Investment Plan for VYJUVE K for the treatment of DEB. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or <URL> Contraindications: VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours.Major Estimate Revision • Nov 13Consensus revenue estimates decrease by 11%, EPS upgradedThe consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$41.4m to US$37.0m. EPS estimate increased from -US$4.15 to -US$0.429 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$151 unchanged from last update. Share price fell 5.0% to US$98.56 over the past week.お知らせ • Oct 31Krystal Biotech, Inc. to Report Q3, 2023 Results on Nov 06, 2023Krystal Biotech, Inc. announced that they will report Q3, 2023 results Pre-Market on Nov 06, 2023Major Estimate Revision • Sep 23Consensus revenue estimates decrease by 11%, EPS upgradedThe consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$33.1m to US$29.6m. EPS estimate increased from -US$4.84 to -US$4.50 per share. Biotechs industry in the US expected to see average net income decline 4.0% next year. Consensus price target of US$149 unchanged from last update. Share price fell 4.2% to US$115 over the past week.株主還元KRYSUS BiotechsUS 市場7D-3.4%-3.0%-0.3%1Y138.4%32.9%26.7%株主還元を見る業界別リターン: KRYS過去 1 年間で32.9 % の収益を上げたUS Biotechs業界を上回りました。リターン対市場: KRYS過去 1 年間で26.7 % の収益を上げたUS市場を上回りました。価格変動Is KRYS's price volatile compared to industry and market?KRYS volatilityKRYS Average Weekly Movement5.5%Biotechs Industry Average Movement10.9%Market Average Movement7.2%10% most volatile stocks in US Market16.2%10% least volatile stocks in US Market3.2%安定した株価: KRYS 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: KRYSの 週次ボラティリティ ( 5% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2016295Krish Krishnanwww.krystalbio.comクリスタル・バイオテック社は、商業段階のバイオテクノロジー企業であり、米国においてアンメット・メディカル・ニーズの高い疾患を治療する遺伝子医薬品の発見、開発、製造、商品化を行っている。同社は、ジストロフィー性表皮水疱症（DEB）治療薬VYJUVEK（beremagene geperpavec-svdt、B-VEC）を商業化している。また、ジストロフィー性表皮水疱症の眼合併症治療薬KB803、神経栄養性角膜炎治療薬KB801、嚢胞性線維症治療薬として第1相臨床試験中のKB407、ハイリー・ヘイリー病治療薬KB111、固形がん治療薬KB707、動的しわ治療薬KB304も開発している；抗PD-1再発/難治性治療薬として第1/2相臨床試験中のKB707、α-1抗トリプシン欠損症治療薬として第1相臨床試験中のKB408、美容皮膚疾患治療薬として第2相臨床試験中のKB301、眼合併症のdeb治療薬として眼科用B-VECのオープンラベル試験中である。クリスタル・バイオテック社は2016年に設立され、ペンシルベニア州ピッツバーグに本社を置いている。もっと見るKrystal Biotech, Inc. 基礎のまとめKrystal Biotech の収益と売上を時価総額と比較するとどうか。KRYS 基礎統計学時価総額US$8.65b収益（TTM）US$225.03m売上高(TTM)US$417.30m39.6xPER（株価収益率21.3xP/SレシオKRYS は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計KRYS 損益計算書（TTM）収益US$417.30m売上原価US$24.34m売上総利益US$392.96mその他の費用US$167.93m収益US$225.03m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）7.63グロス・マージン94.17%純利益率53.92%有利子負債／自己資本比率0%KRYS の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/20 08:12終値2026/05/20 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Krystal Biotech, Inc. 9 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。21 アナリスト機関Caroline PalomequeBerenbergAlec StranahanBofA Global ResearchJustin ZelinB. Riley Securities, Inc.18 その他のアナリストを表示
お知らせ • May 20Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
ライブニュース • May 17Krystal Biotech Gains UK Approval for Vyjuvek in Rare Skin Disorder TreatmentKrystal Biotech received approval from the UK Medicines and Healthcare products Regulatory Agency on May 15, 2026, for Vyjuvek, its wound treatment for dystrophic epidermolysis bullosa (DEB). Vyjuvek targets patients with DEB, a rare genetic disorder with limited treatment options, addressing an area of high medical need. This approval adds a new product to Krystal Biotech's portfolio and positions the company more clearly in rare disease therapies. The MHRA decision gives Krystal Biotech regulatory validation for its approach to treating DEB and opens access to patients in the UK health system. Investors may want to watch how quickly the company can translate this approval into uptake, reimbursement agreements and the generation of real-world data in a rare-disease setting.
分析記事 • May 13There May Be Underlying Issues With The Quality Of Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc. ( NASDAQ:KRYS ) just reported some strong earnings, and the market reacted accordingly with a...
Seeking Alpha • May 06Krystal Biotech: A Q1 Earnings Beat With Multiple Catalysts In 2026 And 2027Summary Krystal Biotech delivered strong Q1 2026 results, with Vyjuvek sales up 32% YoY to $116.4M and gross margin expanding to 95%. KRYS's robust balance sheet ($823M cash and negligible debt) and disciplined capital allocation fund a broad clinical pipeline without dilution risk. Two registrational readouts in 2026 and two more enrolling in 2027, position KRYS for significant pipeline-driven upside beyond Vyjuvek. I reiterate a Strong Buy rating, citing expanding TAM, platform validation, and continued operational outperformance. Read the full article on Seeking Alpha
Reported Earnings • May 05First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 46% per year, which means it is significantly lagging earnings growth.
ナラティブの更新 • May 01KRYS: Future Returns Will Reflect Lung Cancer RMAT Milestone And Oncology Pipeline ExecutionAnalysts have raised their average price target on Krystal Biotech from $291 to $315. This reflects updated models that incorporate Vyjuvek sales assumptions, FY25 financials, and progress across multiple registrational programs following the latest Q4 report and management meetings.
お知らせ • May 20Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
ライブニュース • May 17Krystal Biotech Gains UK Approval for Vyjuvek in Rare Skin Disorder TreatmentKrystal Biotech received approval from the UK Medicines and Healthcare products Regulatory Agency on May 15, 2026, for Vyjuvek, its wound treatment for dystrophic epidermolysis bullosa (DEB). Vyjuvek targets patients with DEB, a rare genetic disorder with limited treatment options, addressing an area of high medical need. This approval adds a new product to Krystal Biotech's portfolio and positions the company more clearly in rare disease therapies. The MHRA decision gives Krystal Biotech regulatory validation for its approach to treating DEB and opens access to patients in the UK health system. Investors may want to watch how quickly the company can translate this approval into uptake, reimbursement agreements and the generation of real-world data in a rare-disease setting.
分析記事 • May 13There May Be Underlying Issues With The Quality Of Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc. ( NASDAQ:KRYS ) just reported some strong earnings, and the market reacted accordingly with a...
Seeking Alpha • May 06Krystal Biotech: A Q1 Earnings Beat With Multiple Catalysts In 2026 And 2027Summary Krystal Biotech delivered strong Q1 2026 results, with Vyjuvek sales up 32% YoY to $116.4M and gross margin expanding to 95%. KRYS's robust balance sheet ($823M cash and negligible debt) and disciplined capital allocation fund a broad clinical pipeline without dilution risk. Two registrational readouts in 2026 and two more enrolling in 2027, position KRYS for significant pipeline-driven upside beyond Vyjuvek. I reiterate a Strong Buy rating, citing expanding TAM, platform validation, and continued operational outperformance. Read the full article on Seeking Alpha
Reported Earnings • May 05First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 46% per year, which means it is significantly lagging earnings growth.
ナラティブの更新 • May 01KRYS: Future Returns Will Reflect Lung Cancer RMAT Milestone And Oncology Pipeline ExecutionAnalysts have raised their average price target on Krystal Biotech from $291 to $315. This reflects updated models that incorporate Vyjuvek sales assumptions, FY25 financials, and progress across multiple registrational programs following the latest Q4 report and management meetings.
お知らせ • Apr 24Krystal Biotech, Inc. to Report Q1, 2026 Results on May 04, 2026Krystal Biotech, Inc. announced that they will report Q1, 2026 results Pre-Market on May 04, 2026
ナラティブの更新 • Apr 17KRYS: Oncology Immunotherapy RMAT And Respiratory Programs Will Test Rare Disease OptimismAnalysts have lifted their average price target on Krystal Biotech by $7, reflecting updates to models around Vyjuvek sales expectations, FY25 financials, and the advancing pipeline, while incorporating a slightly higher discount rate and modestly revised revenue growth, profit margin, and P/E assumptions. Analyst Commentary Recent Street research on Krystal Biotech shows a wide spread of opinion, with several firms lifting price targets following the latest quarterly report and updated models for Vyjuvek and the broader pipeline.
お知らせ • Apr 07Krystal Biotech, Inc., Annual General Meeting, May 15, 2026Krystal Biotech, Inc., Annual General Meeting, May 15, 2026.
Board Change • Apr 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Catherine Mazzacco was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
ナラティブの更新 • Apr 01KRYS: Future CF And Ophthalmology Readouts Will Drive Long Term UpsideKrystal Biotech's analyst price target is maintained at $371, with analysts pointing to refined revenue growth and margin assumptions, along with Q4-driven updates to Vyjuvek forecasts and the broader pipeline, as key supports for the current valuation framework. Analyst Commentary Bullish analysts have been steadily revisiting their models on Krystal Biotech following recent updates on Vyjuvek, the broader pipeline, and Q4 results.
ナラティブの更新 • Mar 18KRYS: Future CF And Ophthalmology Readouts Will Shape Long Term UpsideNarrative Update on Krystal Biotech The analyst fair value estimate for Krystal Biotech has shifted from $336 to $371, with the change largely tied to higher Vyjuvek sales assumptions, updated FY25 forecasts, and continued progress across multiple registrational and pivotal pipeline programs cited in recent research updates. Analyst Commentary Recent research updates on Krystal Biotech point to a cluster of upward price target revisions, with bullish analysts citing refreshed financial models, Vyjuvek launch assumptions, and advancing clinical programs across multiple indications as key inputs.
ナラティブの更新 • Mar 04KRYS: Rising Oncology And Respiratory Pipeline Expectations May Test Rare Disease OptimismThe analyst price target for Krystal Biotech has been raised from $202 to $241, with analysts pointing to updated models that reflect higher Vyjuvek sales assumptions, refined FY25 financials, and advancing registrational trials across multiple programs. Analyst Commentary Recent Street research on Krystal Biotech highlights a series of upward price target revisions clustered around the latest quarterly update, Vyjuvek launch assumptions, and progress across the pipeline.
Price Target Changed • Feb 25Price target increased by 8.3% to US$313Up from US$289, the current price target is an average from 9 analysts. New target price is 17% above last closing price of US$267. Stock is up 47% over the past year. The company is forecast to post earnings per share of US$7.84 for next year compared to US$7.08 last year.
Recent Insider Transactions Derivative • Feb 20Independent Director notifies of intention to sell stockDino Rossi intends to sell 19k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of February. If the sale is conducted around the recent share price of US$261, it would amount to US$5.0m. Since March 2025, Dino has owned 78.69k shares directly. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.
ナラティブの更新 • Feb 18KRYS: Future Returns Will Reflect Vyjuvek Penetration And CF And Oncology Pipeline ExecutionNarrative Update: Krystal Biotech Analyst Price Target Shift The analyst price target for Krystal Biotech has been revised higher from $273.60 to $291.22, with analysts pointing to recent model updates that reflect Vyjuvek demand trends, advancing ophthalmology programs, and early data from the broader pipeline. Analyst Commentary Recent Street research on Krystal Biotech points to a cluster of upward price target revisions, with most commentary tying those changes to product traction for Vyjuvek, the maturing ophthalmology pipeline, and early data in cystic fibrosis and other programs.
Reported Earnings • Feb 18Full year 2025 earnings: Revenues and EPS in line with analyst expectationsFull year 2025 results: EPS: US$7.08 (up from US$3.12 in FY 2024). Revenue: US$389.1m (up 34% from FY 2024). Net income: US$204.8m (up 130% from FY 2024). Profit margin: 53% (up from 31% in FY 2024). The increase in margin was primarily driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) were also in line with analyst expectations. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth.
新しいナラティブ • Feb 16The Rare Disease Rocket ShipKrystal Biotech reports tomorrow, February 17, 2026. The narrative is no longer about survival; it’s about dominance.
Recent Insider Transactions Derivative • Feb 10Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 13k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of February. If the sale is conducted around the recent share price of US$277, it would amount to US$3.5m. Since March 2025, Kathryn has owned 19.32k shares directly. Company insiders have collectively sold US$7.5m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Feb 10+ 1 more updateKrystal Biotech, Inc. to Report Q4, 2025 Results on Feb 17, 2026Krystal Biotech, Inc. announced that they will report Q4, 2025 results Pre-Market on Feb 17, 2026
ナラティブの更新 • Feb 04KRYS: Future CF Data Readouts May Redefine Long Term Upside PotentialAnalysts have increased their price target on Krystal Biotech from $252 to $336, citing updated models that factor in revised assumptions for revenue growth, profit margins, and future P/E multiples following recent clinical data and pipeline updates. Analyst Commentary Recent Street research on Krystal Biotech has centered on a series of higher price targets, with bullish analysts revisiting their models after clinical updates and product pipeline progress.
ナラティブの更新 • Jan 21KRYS: Future Returns Will Reflect 96% Margins And Early CF Pipeline ProgressWe are raising our analyst price target on Krystal Biotech from $223 to $273.60. This reflects updated models that incorporate recent analyst work on Vyjuvek, early KB407 cystic fibrosis data, and revised assumptions for revenue growth, profit margin, and future P/E multiples.
Valuation Update With 7 Day Price Move • Jan 13Investor sentiment improves as stock rises 17%After last week's 17% share price gain to US$292, the stock trades at a forward P/E ratio of 37x. Average trailing P/E is 21x in the Biotechs industry in the US. Total returns to shareholders of 262% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$560 per share.
お知らせ • Jan 09Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 Coral-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic FibrosisKrystal Biotech, Inc. announced a positive interim clinical update from the highest dose cohort of CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407.
Price Target Changed • Jan 09Price target increased by 9.3% to US$250Up from US$229, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$249. Stock is up 59% over the past year. The company is forecast to post earnings per share of US$6.74 for next year compared to US$3.12 last year.
お知らせ • Jan 08Krystal Biotech to Announce Interim Clinical Update from Highest Dose Cohort of Phase 1 CORAL-1 Study Evaluating KB407 in Patients with Cystic FibrosisKrystal Biotech, Inc. announced that it will host an investor conference call and webcast on January 8, 2026, to disclose an interim clinical update from CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis. The interim clinical update will focus on results from patients in the highest dose cohort of CORAL-1 and include molecular assessments of KB407 transduction and wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein expression following inhaled administration of KB407.
ナラティブの更新 • Jan 07KRYS: Elevated Expectations For Rare Disease Portfolio May Prove UnsustainableAnalysts have lifted their Krystal Biotech fair value estimate from US$176 to US$202, citing higher price targets from recent research, improving access to capital for biotech, and support from Vyjuvek revenue trends and gross margin performance. Analyst Commentary Recent Street research has generally framed Krystal Biotech within a more constructive backdrop for U.S. biotech, pointing to supportive data readouts, active dealmaking by larger peers, and what some describe as better access to capital.
Price Target Changed • Dec 18Price target increased by 7.8% to US$229Up from US$213, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$236. Stock is up 51% over the past year. The company is forecast to post earnings per share of US$6.58 for next year compared to US$3.12 last year.
ナラティブの更新 • Dec 15KRYS: Future Returns Will Reflect 96% Margins And Expanding International UptakeAnalysts have nudged their price target on Krystal Biotech higher to about $220, reflecting stronger than expected Vyjuvek revenue, early traction from the Germany launch, and exceptionally high gross margins that support the company’s long term profitability outlook. Analyst Commentary Bullish analysts point to the latest quarter as evidence that Krystal Biotech is executing ahead of expectations, with Vyjuvek demand and geographic expansion translating into faster top line growth and stronger earnings power than previously modeled.
ナラティブの更新 • Dec 01KRYS: Future Results Will Reflect Margin Strength and International Launch PerformanceAnalysts have raised their price target for Krystal Biotech to $220, up from $216. They cite stronger-than-expected Vyjuvek revenue, international sales growth, and robust gross margins as key drivers behind the increased valuation.
ナラティブの更新 • Nov 17KRYS: Future Momentum Will Depend on Gross Margin Strength and Pipeline ProgressAnalysts have increased Krystal Biotech’s price target from $212.50 to $223.00. They cite stronger-than-expected Vyjuvek revenue, expansion in Germany, and improved profit margins as key factors supporting the higher valuation.
分析記事 • Nov 10Investors Shouldn't Be Too Comfortable With Krystal Biotech's (NASDAQ:KRYS) EarningsKrystal Biotech, Inc.'s ( NASDAQ:KRYS ) robust earnings report didn't manage to move the market for its stock. Our...
Major Estimate Revision • Nov 10Consensus EPS estimates increase by 19%The consensus outlook for earnings per share (EPS) in fiscal year 2025 has improved. 2025 revenue forecast increased from US$383.7m to US$388.8m. EPS estimate increased from US$5.08 to US$6.03 per share. Net income forecast to grow 23% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target up from US$213 to US$220. Share price was steady at US$198 over the past week.
Reported Earnings • Nov 04Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$2.74 (up from US$0.95 in 3Q 2024). Revenue: US$97.8m (up 17% from 3Q 2024). Net income: US$79.4m (up 192% from 3Q 2024). Profit margin: 81% (up from 32% in 3Q 2024). The increase in margin was primarily driven by lower expenses. Revenue exceeded analyst estimates by 4.7%. Earnings per share (EPS) also surpassed analyst estimates by 145%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 114% per year but the company’s share price has only increased by 37% per year, which means it is significantly lagging earnings growth.
ナラティブの更新 • Nov 01KRYS: Global Expansion And Pipeline Shifts Will Shape Near-Term PerformanceKrystal Biotech's average analyst price target has been revised downward, with a reduction of up to $10 per share. Analysts cite updated product prioritizations, mixed quarterly results, and cautious near-term revenue forecasts.
お知らせ • Oct 21Krystal Biotech, Inc. to Report Q3, 2025 Results on Nov 03, 2025Krystal Biotech, Inc. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 03, 2025
ナラティブの更新 • Oct 18Global Expansion And Clinical Readouts Will Unlock New MarketsThe analyst consensus price target for Krystal Biotech has increased from $205.20 to $212.50. This change reflects updated evaluations as analysts factor in new product development priorities and ongoing commercial performance.
お知らせ • Oct 15Krystal Biotech, Inc. Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic KeratitisKrystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK). The FDA's platform technology designation program is intended to provide efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies. Potential benefits of the designation may include early and more frequent engagement with the FDA during clinical development as well as the opportunity to leverage manufacturing and nonclinical safety data from a prior product using the designated platform technology, such as VYJUVEK, in submissions to the FDA. The FDA may also consider previous inspectional findings related to the manufacture of a drug that incorporates the designated platform technology. To be eligible for a platform technology designation, a technology must be well-understanding and reproducible, used in an FDA-approved drug or biologic product, such as VYJ UVEK, have the potential to support the development of multiple drugs or biologic products without compromising quality, manufacturing, or safety, and have a reasonable likelihood to bring significant efficiencies to the development or manufacturing process as well as to the FDA review process. Drug product applications that are then recognized by the FDA to incorporate this technology may leverage the potential benefits of the designation. KB801 is a redosable eye drop gene treatment designed to enable sustained, localized expression and secretion of vein growth factor (NGF) by epithelial cells in the front of the eye for the treatment of NK, a rare,degenerative corneal disease that leads to corneal epithelial defects, ulcers, and perforation. Recombinant NGF eye drops have been shown to significantly improve corneal healing and are approved for the treatment of NK in multiple jurisdictions worldwide, but rapid clearance from the eye requires intensive administration six times a day, limiting therapeutic utility. By enabling the cells of the front of the eye to produce NGF locally, KB801 has the potential to significantly reduce the treatment burden for patients while also maintaining more consistent NGF levels in the front of the eye. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics.
分析記事 • Oct 09Market Participants Recognise Krystal Biotech, Inc.'s (NASDAQ:KRYS) Earnings Pushing Shares 29% HigherThe Krystal Biotech, Inc. ( NASDAQ:KRYS ) share price has done very well over the last month, posting an excellent gain...
お知らせ • Sep 16Krystal Biotech Announces FDA Approval of Updated VYJUVEK LabelKrystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK®? (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in the United States, as well as results from the open label extension study conducted in the United States and published earlier this year, which collectively reinforce the long-term safety and efficacy of VYJUVEK across patients of all ages, including in cases of patient or caregiver application. VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEk was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVE K is approved in the United States, Europe, and Japan. VYJUVE k gel may be applied by a healthcare provider, a caregiver, or the patient. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.ash hands and wear protective gloves when changing wound dressings. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics.
Reported Earnings • Aug 04Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2025 results: EPS: US$1.33 (up from US$0.54 in 2Q 2024). Revenue: US$96.0m (up 37% from 2Q 2024). Net income: US$38.3m (up 146% from 2Q 2024). Profit margin: 40% (up from 22% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 4.4%. Earnings per share (EPS) also surpassed analyst estimates by 14%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.
お知らせ • Jul 29Krystal Biotech, Inc. to Report Q2, 2025 Results on Aug 04, 2025Krystal Biotech, Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 04, 2025
お知らせ • Jul 25Krystal Biotech Announces Approval of VYJUVEK by Japan's Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that on July 24, 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB), starting from birth. VYJUVEK is the first genetic medicine approved in Japan for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The Japanese approval allows for dosing at home or in a healthcare setting, with the option for administration by patients or their family members. As per the approval issued by the MHLW, VYJUveK is intended for use only in patients with a definite diagnosis of dystrophic epidermorysis bullosa. Genetic testing is not a requirement for treatment. VYJUVE K is the first genetic medicine approved In Japan for home administration after undergoing regulatory evaluation and environmental safety confirmation for type 1 use in accordance with the Cartagena Act. The timing for availability of VYJUVEK in Japan will depend on completion of reimbursement procedures currently underway. The Company currently expects to launch in Japan by the end of this year. The approval by Japan's MHLW was based on a comprehensive clinical dataset, which included results from an open label extension study conducted in Japanese patients. Results from the Japanese open label extension study closely mirrored prior clinical experience, including the Company's Phase 3 study in the United States, with all four patients that completed the study achieving the primary study endpoint of full wound closure at six months. VYJUVEk was also well tolerated and exhibited a safety profile in Japanese patients that was consistent with previous studies. The re- examination period for VYJUVEK In Japan is ten years. VYJUVEV was previously approved by the Food and Drug Administration in the United States in May 2023 and by the European Commission in April 2025. JAPAN INDICATION: Dystrophic epidermolytic bullosa.
お知らせ • Jul 09Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of Kb801 for the Treatment of Neurotrophic KeratitisKrystal Biotech, Inc. announced that the first patient has been dosed in its Phase 1/2 clinical trial ("EMERALD-1"), a 2:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of neurotrophic keratitis (NK). KB801 is a redosable eye drop gene therapy in development for the treatment of NK, a degenerative corneal disease characterized by damage or loss of function in the neurons innervating the eye leading to corneal epithelial defects, ulcers, and perforation. Left untreated, NK can result in severe vision loss. Although NK is a rare disease with an estimated prevalence in the range of 10 to 50 cases per 100,000, claims data analyses suggest awareness and diagnosis rates are on the rise in the United States. Based on available claims data, an estimated 68,000 patients in the United States had a NK claim in 2024, up over 115% from 31,000 patients with a NK claim in 2020. EMERALD-1 is a randomized, double-masked, multicenter, placebo-controlled study evaluating KB801, administered as an eye drop, for the treatment of NK. Up to 27 adults with Stage 2 or Stage 3 NK, as defined by the Mackie criteria, will be enrolled and randomized 2:1 to receive either KB801, at a concentration of 1010 PFU/mL, or placebo topically to the study eye twice weekly for 8 weeks. The primary objective of EMERALD-1 is to evaluate the safety and tolerability of topical ocular administration of KB801 in patients with NK. The secondary objective is evaluation of efficacy based on the proportion of patients with complete durable healing of corneal epithelium at 8 weeks, defined as 0 mm corneal fluorescein staining in the area of the corneal lesion at both week 8 and 0 mm corneal fluorescein staining in the same area at week 10, as assessed by a masked reader. Additional exploratory efficacy measures will include change in corneal lesion size from baseline, each assessed at weeks 4, 6, 8, 10, and 20, as well as evaluations of corneal sensation and patient-reported symptom burden. More details of the EMERALD-1 study can be found at www.clinicaltrials.gov under NCT identifier NCT06999733.
お知らせ • Jun 25Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of Kb803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the first patient has been dosed in its Phase 3 clinical trial ("IOLITE"), an intra-patient, double-blind, multicenter, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. KB803 is designed to deliver two copies of the COL7A1 transgene to the corneal epithelium and enable local type VII collagen production in the front of the eye. IOLITE is an intra- patient, double-blind, placebo-controlled, multicenter Phase 3 study with a crossover design to evaluate KB803, administered as an eye drop, for the treatment and prevention of Corneal abrasions in DEB patients, 6 months of age or older. Patients seeking to participate in IOLITE must first enroll in the ongoing natural history study and complete a 12-week run-in period, during which they report the number of days that they experience symptoms of corneal abrasions. Subjects meeting the inclusion criteria following the 12-week run-in are eligible to participate in the IOLITE trial. The goal of therapy with KB803 is to address the fundamental disease-causing mechanism at the molecular level, by providing the patient's epithelial cells of the eye with the template to make normal type VII collagen locally. In a DEB patient treated under compassionate use with clinical observations reported the New England Journal of Medicine, regular eye drop administration was well tolerated with full corneal healing observed at three months, as well as significant visual acuity improvement from hand motion to 20/25 by eight months.
お知らせ • Jun 03Krystal Biotech Presents Phase 1/2 Clinical Trial Results for Inhaled KB707 in Lung Cancer at ASCO 2025On June 2, 2025, Krystal Biotech, Inc. provided a clinical update on the monotherapy cohort from its Phase 1/2 clinical trial of inhaled KB707 for the treatment of solid tumors of the lung, which was presented by Wen Wee Ma, MD, Enterprise Vice Chair, Research, Cancer Institute, Cleveland Clinic, in a poster entitled “Inhaled KB707, a Novel HSV-based Immunotherapy, as a Monotherapy in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs: Efficacy and Safety Results from a Phase 1/2 Study” at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
分析記事 • May 23Why We're Not Concerned Yet About Krystal Biotech, Inc.'s (NASDAQ:KRYS) 26% Share Price PlungeTo the annoyance of some shareholders, Krystal Biotech, Inc. ( NASDAQ:KRYS ) shares are down a considerable 26% in the...
Reported Earnings • May 07First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst quarter 2025 results: EPS: US$1.24 (up from US$0.033 in 1Q 2024). Revenue: US$88.2m (up 95% from 1Q 2024). Net income: US$35.7m (up US$34.8m from 1Q 2024). Profit margin: 41% (up from 2.1% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 8.3%. Earnings per share (EPS) also missed analyst estimates by 12%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 102% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth.
お知らせ • Apr 28Krystal Biotech Announces European Commission Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. VYJUveK is the first corrective medicine approved in Europe for the treatment of DEB. The approval granted by the EC allows for flexible VYJUVEK dosing either at home or in healthcare setting, with the option for patient or caregiver administration if deemed appropriate by a healthcare professional. The EC approval follows the positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in February and was based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company's open label extension study and real-world experience in the United States. VYJUVEk was approved by the FDA in the United States in May 2023 and is also under review for approval by Japan's Pharmaceuticals and Medical Devices Agency with a decision expected in 2H 2025. VYJUVE K is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patient from birth with dystrophic epider molysis bullosa with mutation(s) in the collagen type VII alpha1 chain (COL7A1).
お知らせ • Apr 17Krystal Biotech, Inc. to Report Q1, 2025 Results on May 06, 2025Krystal Biotech, Inc. announced that they will report Q1, 2025 results Pre-Market on May 06, 2025
お知らせ • Apr 04Krystal Biotech, Inc., Annual General Meeting, May 16, 2025Krystal Biotech, Inc., Annual General Meeting, May 16, 2025.
Recent Insider Transactions Derivative • Mar 14Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of March. If the sale is conducted around the recent share price of US$178, it would amount to US$4.5m. For the year to December 2018, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • Mar 02Executive VP & Chief Accounting Officer exercised options and sold US$1.0m worth of stockOn the 28th of February, Kathryn Romano exercised options to acquire 6k shares at no cost and sold these for an average price of US$179 per share. This trade did not impact their existing holding. Since March 2024, Kathryn has owned 12.94k shares directly. Company insiders have collectively sold US$3.9m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Feb 28Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic EpidermolysisKrystal Biotech, Inc. welcomed the European Medicines Agency's (EMA's) announcement that its Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK® (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. The CHMP's positive opinion includes support for administration of VYJUVEK in either a health care setting (e.g., a clinic) or at home. If deemed appropriate by a healthcare professional, trained patients or caregivers may also apply VYJUVEK. The positive opinion issued by the CHMP is based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, published in Nature Medicine and the New England Journal of Medicine, respectively, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration. The long-term safety and efficacy of B-VEC is further supported by results from the Company's open label extension study completed in the United States as well as real-world experience with VYJUVEK since launching the United States in 2023.
Valuation Update With 7 Day Price Move • Feb 26Investor sentiment improves as stock rises 16%After last week's 16% share price gain to US$181, the stock trades at a forward P/E ratio of 25x. Average trailing P/E is 17x in the Biotechs industry in the US. Total returns to shareholders of 182% over the past three years.
Seeking Alpha • Feb 21Krystal Biotech Soars As Q4 Earnings Put Blockbuster Commercialization In FocusSummary Krystal Biotech's VYJUVEK shows strong growth, with 2025 sales expected to exceed $1B, bolstered by launches in the EU and Japan. Q4 earnings beat EPS expectations but slightly missed revenue forecasts; however, management's 2025 outlook coming catalysts drove a strong rally in shares. Key 2025 catalysts include VYJUVEK's EU and Japan launches, Phase 3 ocular DEB results, and progress in CF and lung gene therapy. KRYS stock remains a STRONG BUY with a $225/share 12-month target, driven by impressive growth and new market opportunities. Read the full article on Seeking Alpha
Reported Earnings • Feb 19Full year 2024 earnings: EPS exceeds analyst expectationsFull year 2024 results: EPS: US$3.12 (up from US$0.40 in FY 2023). Revenue: US$290.5m (up 473% from FY 2023). Net income: US$89.2m (up US$78.2m from FY 2023). Profit margin: 31% (up from 22% in FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 7.9%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 87% per year but the company’s share price has only increased by 45% per year, which means it is significantly lagging earnings growth.
お知らせ • Feb 06Krystal Biotech, Inc. to Report Q4, 2024 Results on Feb 19, 2025Krystal Biotech, Inc. announced that they will report Q4, 2024 results Pre-Market on Feb 19, 2025
お知らせ • Dec 19Krystal Biotech Announces Early Evidence of Monotherapy Activity in Heavily Pre-Treated Patients with Advanced Non-Small Cell Lung CancerKrystal Biotech, Inc. announced initial clinical results from its ongoing KYANITE-1 study evaluating inhaled KB707 in patients with solid tumors of the lung. KB707 administered via inhalation demonstrated early evidence of monotherapy activity that was most pronounced in patients with advanced non-small cell lung cancer (NSCLC), where an objective response rate (ORR) of 27% and disease control rate (DCR) of 73% were observed as of data cut-off on December 6, 2024. KYANITE-1 is an ongoing, open-label, multicenter, dose escalation and expansion study evaluating inhaled KB707 for the treatment of solid tumors of the lung. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient's tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation.
Recent Insider Transactions Derivative • Dec 15Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of December. If the sale is conducted around the recent share price of US$173, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Dec 13Krystal Biotech, Inc. Announces Initial Clinical Update for Rare Respiratory Disease Programs KB408 and KB407Krystal Biotech, Inc. announced clinical data updates for both KB408 and KB407, the Company's clinical-stage, inhaled genetic medicine programs in Phase 1 for the treatment of rare respiratory diseases. Today's updates include molecular data from multiple patients demonstrating SERPINA1 delivery and alpha-1 antitrypsin (AAT) expression within the respiratory tract following KB408 administration as well as safety and tolerability data for both KB407 and KB408 that, taken together, highlight the potential of the Company's platform to safely deliver genetic cargo to the lung. KB408 for the treatment of alpha-1 antitryps in lung disease. KB408 is being evaluated in the Company's Phase 1 SERPENTINE-1 study. The Company expects to report data from Cohort 3 in 1H 2025, including data on CFTR gene delivery and expression in patients with cystic fibrosis. VYJUVEK®? is the Company's first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa.
お知らせ • Dec 10Krystal Biotech Provides Update on EMA’s Ongoing Regulatory Review of B-VEC for Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company’s Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) that was scheduled for December 6, 2024, and asked the Company to submit written responses to the remaining outstanding issues. There are no Major Objections outstanding from the EMA with respect to the full approval of B-VEC. The Company now anticipates a CHMP opinion in First Quarter 2025 while the launch timelines remain unchanged with a commercial launch in Germany still planned for Second Quarter 2025. About Dystrophic Epidermolysis Bullosa (DEB) DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal. About B-VEC and VYJUVEK B-VEC is a non-invasive, redosable gene therapy built to deliver two copies of the COL7A1 gene to treat DEB at the molecular level by providing the patient’s cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. B-VEC was approved by U.S. Food and Drug Agency (FDA) in May 2023 for the treatment of DEB and is marketed and sold in the U.S. under the name VYJUVEK®.
お知らせ • Oct 28Krystal Biotech, Inc. to Report Q3, 2024 Results on Nov 04, 2024Krystal Biotech, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 04, 2024
Seeking Alpha • Oct 14Krystal Biotech: Q4 Catalysts Expected With VYJUVEK Revenue Growth Pressing OnSummary The company anticipates significant Q4 2024 data releases for KB707 in solid tumors and KB408 in AATD lung disease, potentially boosting shareholder value. Jeune Therapeutics, a subsidiary, shows promise in aesthetics with positive phase 1 data, changing the treatment paradigm in the aesthetics market space. VYJUVEK, approved for DEB, saw a 55.3% revenue increase in Q2 2024, with potential European expansion pending MAA approval. Financially stable with $628.9M cash, but may need additional funding within 12 months; has a $150M ATM agreement with Cowen & Co. LLC. in place if necessary. Read the full article on Seeking Alpha
Recent Insider Transactions Derivative • Sep 15Founder notifies of intention to sell stockSuma Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of September. If the sale is conducted around the recent share price of US$199, it would amount to US$5.0m. Since December 2023, Suma's direct individual holding has decreased from 1.66m shares to 1.62m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.
新しいナラティブ • Aug 29Expanding Global Reach With VYJUVEK Set To Skyrocket Revenue And Sharpen Market Edge International expansion and upcoming product launches indicate significant potential for revenue growth and market diversification.
Price Target Changed • Aug 28Price target increased by 7.5% to US$204Up from US$190, the current price target is an average from 9 analysts. New target price is approximately in line with last closing price of US$204. Stock is up 60% over the past year. The company is forecast to post earnings per share of US$2.59 for next year compared to US$0.40 last year.
Major Estimate Revision • Aug 05Consensus revenue estimates increase by 11%The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$269.1m to US$299.6m. EPS estimate increased from US$2.33 to US$2.67 per share. Net income forecast to grow 72% next year vs 9.7% decline forecast for Biotechs industry in the US. Consensus price target of US$193 unchanged from last update. Share price fell 12% to US$181 over the past week.
Seeking Alpha • Jul 31Krystal Biotech: High Valuation Merits Caution Ahead Of Q2 Earnings (Rating Downgrade)Summary Krystal Biotech's Q1 2024 revenue increased to $45.25 million but fell short of analyst expectations of $47.37 million. Analysts expect Q2 earnings to be $65.49 million. Vyjuvek's patient adherence rate dropped slightly to 91% in Q1 from 96% in the previous quarter. Krystal's pipeline, beyond dermatological and aesthetic pursuits, is pretty speculative and pursuing highly contested indications. I recommend a rating downgrade "hold" for Krystal due to its high valuation. Read the full article on Seeking Alpha
お知らせ • Jul 26Krystal Biotech, Inc. to Report Q2, 2024 Results on Aug 05, 2024Krystal Biotech, Inc. announced that they will report Q2, 2024 results Pre-Market on Aug 05, 2024
Recent Insider Transactions Derivative • Jun 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of June. If the sale is conducted around the recent share price of US$177, it would amount to US$4.4m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2023, Krish's direct individual holding has decreased from 1.66m shares to 1.61m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • May 22Independent Director notifies of intention to sell stockJulian Gangolli intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of May. If the sale is conducted around the recent share price of US$164, it would amount to US$3.3m. Since March 2024, Julian has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$17m more than they bought, via options and on-market transactions in the last 12 months.
Major Estimate Revision • May 13Consensus EPS estimates increase by 16%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$260.0m to US$268.7m. EPS estimate increased from US$1.90 to US$2.20 per share. Net income forecast to grow 52% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price was steady at US$155 over the past week.
お知らせ • Apr 28Krystal Biotech, Inc. to Report Q1, 2024 Results on May 06, 2024Krystal Biotech, Inc. announced that they will report Q1, 2024 results at 9:30 AM, US Eastern Standard Time on May 06, 2024
お知らせ • Apr 23Krystal Biotech, Inc Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the LungKrystal Biotech, Inc. announced that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung, for the treatment of patients with locally advanced or metastatic solid tumors of the lung. The KYANITE-1 clinical trial is an open-label, multicenter, dose escalation and expansion study to evaluate inhaled KB707 monotherapy in patients with advanced solid tumor malignancies affecting the lungs. Details of the KYANITE-1 study can be found at www.clinicaltrials.gov under NCT identifier: NCT06228326. In February 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. This is the second Fast Track Designation for the KB707 program. In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-PD-1 relapsed/refractory locally advanced or metastatic melanoma. IL-2 and IL-12 are secreted cytokines with complementary functions promoting cell-mediated immunity in humans. Both IL-2 and IL-12 have been shown to elicit anti-tumor immune responses in preclinical models and in clinical settings and have been extensively studied for their potential in cancer immunotherapy. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient’s tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation.
Major Estimate Revision • Apr 16Consensus EPS estimates increase by 11%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$254.7m to US$261.7m. EPS estimate increased from US$1.75 to US$1.95 per share. Net income forecast to grow 395% next year vs 9.2% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price fell 5.4% to US$170 over the past week.
お知らせ • Apr 05Krystal Biotech, Inc., Annual General Meeting, May 17, 2024Krystal Biotech, Inc., Annual General Meeting, May 17, 2024, at 16:00 US Eastern Standard Time. Agenda: To elect the three Class I director nominees named in the Proxy Statement; to ratify the appointment of KPMG LLP as company's independent registered public accounting firm for company's fiscal year ending December 31, 2024; to consider and act upon a non-binding, advisory vote on the compensation of company's named executive officers; and to transact such other business as may properly come before the Annual Meeting or any adjournment(s) or postponement(s) of the Annual Meeting.
Recent Insider Transactions Derivative • Mar 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of March. If the sale is conducted around the recent share price of US$172, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Krish's direct individual holding has decreased from 1.73m shares to 1.64m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • Feb 28Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of February. If the sale is conducted around the recent share price of US$111, it would amount to US$900k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.
Seeking Alpha • Feb 28Krystal Biotech's Future Brightens With Vyjuvek's Robust LaunchSummary Vyjuvek's Successful Launch: Q4 earnings show strong sales and high patient compliance for Vyjuvek, Krystal Biotech's DEB treatment. Financial Health: The Company boasts a robust balance sheet with significant cash reserves, suggesting a low likelihood of near-term financing needs. Market Sentiment: Despite mixed stock performance, strong institutional ownership and projected revenue growth signal positive market sentiment. Investment Recommendation: KRYS remains a "Strong Buy," with Vyjuvek's success bolstering confidence in the company's future prospects. Read the full article on Seeking Alpha
Price Target Changed • Feb 27Price target increased by 14% to US$176Up from US$154, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$170. Stock is up 108% over the past year. The company is forecast to post earnings per share of US$1.46 for next year compared to US$0.40 last year.
New Risk • Feb 27New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (57% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (9.8% increase in shares outstanding).
Breakeven Date Change • Feb 26Forecast breakeven date moved forward to 2024The 8 analysts covering Krystal Biotech previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$115.0m in 2024. Average annual earnings growth of 46% is required to achieve expected profit on schedule.
お知らせ • Feb 21Krystal Biotech, Inc. to Report Q4, 2023 Results on Feb 26, 2024Krystal Biotech, Inc. announced that they will report Q4, 2023 results Pre-Market on Feb 26, 2024
Seeking Alpha • Feb 20Krystal Biotech: Ready For LaunchSummary Krystal Biotech, Inc. has gained 50% in the past year after receiving FDA approval for its gene therapy to treat dystrophic epidermolysis bullosa. The company's pipeline also includes early-stage treatments for oncology and cystic fibrosis, with some key early-stage trial milestones expected by 2024. Analysts have given positive ratings to the stock, with price targets ranging from $139 to $180 per share. The company ended Q3 with nearly $600 million in cash and marketable securities. What is ahead for Krystal Biotech in the quarters ahead is highlighted in the paragraphs below. Read the full article on Seeking Alpha
Recent Insider Transactions Derivative • Jan 24Executive VP & Chief Accounting Officer notifies of intention to sell stockKathryn Romano intends to sell 3k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of January. If the sale is conducted around the recent share price of US$130, it would amount to US$325k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Jan 05Krystal Biotech Receives Permanent J-Code (J3401) for VYJUVEK®Krystal Biotech, Inc. announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code for VYJUVEK became effective on January 1, 2024. J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional. J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing. VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
Recent Insider Transactions Derivative • Dec 13Founder notifies of intention to sell stockKrish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of December. If the sale is conducted around the recent share price of US$107, it would amount to US$2.7m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2022, Krish's direct individual holding has decreased from 1.78m shares to 1.66m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Nov 29Krystal Biotech Announces EMA Validation of Marketing Authorization Application for Vyjuvek for the Treatment of Dystrophic Epidermolysis BullosaKrystal Biotech, Inc. announced that the Company's Marketing Authorization Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024. In September 2023, Krystal Biotech received a positive opinion from the EMA Pediatric Committee on the Pediatric Investment Plan for VYJUVE K for the treatment of DEB. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or <URL> Contraindications: VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours.
Major Estimate Revision • Nov 13Consensus revenue estimates decrease by 11%, EPS upgradedThe consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$41.4m to US$37.0m. EPS estimate increased from -US$4.15 to -US$0.429 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$151 unchanged from last update. Share price fell 5.0% to US$98.56 over the past week.
お知らせ • Oct 31Krystal Biotech, Inc. to Report Q3, 2023 Results on Nov 06, 2023Krystal Biotech, Inc. announced that they will report Q3, 2023 results Pre-Market on Nov 06, 2023
Major Estimate Revision • Sep 23Consensus revenue estimates decrease by 11%, EPS upgradedThe consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$33.1m to US$29.6m. EPS estimate increased from -US$4.84 to -US$4.50 per share. Biotechs industry in the US expected to see average net income decline 4.0% next year. Consensus price target of US$149 unchanged from last update. Share price fell 4.2% to US$115 over the past week.
