Vertex Pharmaceuticals（VRTXD）株式概要ヴァーテックス・ファーマシューティカルズ・インコーポレイテッドはバイオテクノロジー企業で、嚢胞性線維症（CF）治療薬の開発と商品化に取り組んでいる。 詳細VRTXD ファンダメンタル分析スノーフレーク・スコア評価3/6将来の成長2/6過去の実績3/6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30.2%で取引されている 収益は年間13.02%増加すると予測されています 今年は黒字化を達成 リスク分析リスクチェックの結果、VRTXD 、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VRTXD Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$4.5298.9% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-989m19b2016201920222025202620282031Revenue US$19.5bEarnings US$6.9bAdvancedSet Fair ValueView all narrativesVertex Pharmaceuticals Incorporated 競合他社Gilead SciencesSymbol: NasdaqGS:GILDMarket cap: US$162.0bRegeneron PharmaceuticalsSymbol: NasdaqGS:REGNMarket cap: US$64.1bAmgenSymbol: NasdaqGS:AMGNMarket cap: US$178.5bCSLSymbol: ASX:CSLMarket cap: AU$47.8b価格と性能株価の高値、安値、推移の概要Vertex Pharmaceuticals過去の株価現在の株価US$4.5252週高値US$5.1752週安値US$3.63ベータ0.301ヶ月の変化1.23%3ヶ月変化-7.10%1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化17.58%最新ニュースお知らせ • May 06Vertex Pharmaceuticals Incorporated Reaffirms Earnings Guidance for Full Year 2026Vertex Pharmaceuticals Incorporated reaffirmed earnings guidance for full year 2026. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.お知らせ • Apr 07Vertex Pharmaceuticals Incorporated to Report Q1, 2026 Results on May 04, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 04, 2026お知らせ • Apr 06Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026.お知らせ • Apr 01+ 1 more updateVertex Pharmaceuticals Incorporated Announces U.S. FDA Approval of Expanded Use of ALYFTREK (Vanzacaftor/Tezacaftor/Ivacaftor)Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approximately 95% of people with CF in the U.S. are now eligible for treatment with a CFTR modulator.お知らせ • Mar 10Vertex Pharmaceuticals Incorporated Announces Positive Interim Analysis Results for Povetacicept in Rainier Phase 3 TrialVertex Pharmaceuticals Incorporated announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001). Povetacicept was generally safe and well tolerated. RAINIER is a global Phase 3 randomized, double-blind, placebo-controlled pivotal trial of povetacicept 80 mg administered subcutaneously every four weeks versus placebo on top of standard of care. A total of 605 patients were randomized in the trial, N=557 are in the main cohort, of which N=199 are in the interim analysis population, and N=48 patients are in an exploratory cohort. These patients are representative of real world IgAN patients at risk of kidney disease progression. The median time from diagnosis of IgAN to randomization in the main cohort was approximately 3.8 years and the trial patients had high rates of background supportive care, with 97.8% of patients on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARBs), and 67.7% of patients on sodium-glucose co-transporter 2(SGLT2) inhibitors, the latter representing the highest percentage in recently completed IgAN trials. For the interim analysis, the trial’s primary endpoint is percent change from baseline in 24-hour UPCR, and the two alpha-controlled secondary endpoints are percent change from baseline in serum Gd-IgA1 and the proportion of patients to achieve hematuria resolution, all at Week 36. Exploratory endpoints for this interim analysis included the proportion of patients with 24-hour UPCR. Povetacicept was generally safe and well tolerated. The data below reflect 557 patients in the main cohort with a mean duration of treatment of 33.7 weeks for the povetacicept cohort and 33.4 weeks for placebo. Adverse Events Occurring During the Treatment Period in the Safety Population: Placebo N=185 n (%) Patients with any adverse event during the treatment emergent period 145 (78.4), Povetacicept N=372 n (%) Patients with any adverse event during the treatment emergent period 279 (75.0). Adverse events occurring in =10% of patients in either group: Upper respiratory tract infection 21 (11.4) for placebo, 68 (18.3) for povetacicept; Nasopharyngitis 23 (12.4) for placebo, 36 (9.7) for povetacicept; Injection site reactions 4 (2.2) for placebo, 54 (14.5) for povetacicept. Injection site reactions (ISR) were identified using a pre-specified set of Preferred Terms (including, for example, injection site reaction and injection site erythema). All ISRs were non-serious and mild or moderate in severity. Serious AEs occurred in 4.3% (8 out of 185 patients) of the placebo group and 3.0% (11 out of 372 patients) of the povetacicept group. The same incidence of SAEs of infection (0.5%) occurred in both the placebo and povetacicept groups. The U.S. Food and Drug Administration (FDA) has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex has already submitted several modules and will complete the full BLA submission by the end of March for potential accelerated approval. Vertex is using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which promote B cell activation, differentiation and/or survival, and provides B cell control by inhibiting the ability of BAFF and APRIL to drive the pathogenesis of multiple autoimmune diseases. Due to its engineered TACI domain, povetacicept has demonstrated improved binding affinity, potency, pharmacokinetics, and/or tissue distribution compared to other APRIL, BAFF, and dual BAFF+APRIL inhibitors in preclinical studies. Povetacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN. Povetacicept is the only dual BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Expansion into additional indications for povetacicept is advancing with the ongoing Phase 2/3 OLYMPUS trial in primary membranous nephropathy (pMN) and the expected start of the ETNA Phase 2 trial in generalized myasthenia gravis (gMG) in the first half of 2026. Povetacicept is an investigational agent and has not been approved by health authorities.お知らせ • Mar 05Vertex Pharmaceuticals Incorporated Presents New Data on JOURNAVX for Effective Pain Management Following Aesthetic and Reconstructive ProceduresVertex Pharmaceuticals Incorporated announced data from a Phase 4 study of JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days. JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting. These data will be presented on March 6, 2026 during the AAPM meeting.最新情報をもっと見るRecent updatesお知らせ • May 06Vertex Pharmaceuticals Incorporated Reaffirms Earnings Guidance for Full Year 2026Vertex Pharmaceuticals Incorporated reaffirmed earnings guidance for full year 2026. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.お知らせ • Apr 07Vertex Pharmaceuticals Incorporated to Report Q1, 2026 Results on May 04, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 04, 2026お知らせ • Apr 06Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026.お知らせ • Apr 01+ 1 more updateVertex Pharmaceuticals Incorporated Announces U.S. FDA Approval of Expanded Use of ALYFTREK (Vanzacaftor/Tezacaftor/Ivacaftor)Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approximately 95% of people with CF in the U.S. are now eligible for treatment with a CFTR modulator.お知らせ • Mar 10Vertex Pharmaceuticals Incorporated Announces Positive Interim Analysis Results for Povetacicept in Rainier Phase 3 TrialVertex Pharmaceuticals Incorporated announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001). Povetacicept was generally safe and well tolerated. RAINIER is a global Phase 3 randomized, double-blind, placebo-controlled pivotal trial of povetacicept 80 mg administered subcutaneously every four weeks versus placebo on top of standard of care. A total of 605 patients were randomized in the trial, N=557 are in the main cohort, of which N=199 are in the interim analysis population, and N=48 patients are in an exploratory cohort. These patients are representative of real world IgAN patients at risk of kidney disease progression. The median time from diagnosis of IgAN to randomization in the main cohort was approximately 3.8 years and the trial patients had high rates of background supportive care, with 97.8% of patients on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARBs), and 67.7% of patients on sodium-glucose co-transporter 2(SGLT2) inhibitors, the latter representing the highest percentage in recently completed IgAN trials. For the interim analysis, the trial’s primary endpoint is percent change from baseline in 24-hour UPCR, and the two alpha-controlled secondary endpoints are percent change from baseline in serum Gd-IgA1 and the proportion of patients to achieve hematuria resolution, all at Week 36. Exploratory endpoints for this interim analysis included the proportion of patients with 24-hour UPCR. Povetacicept was generally safe and well tolerated. The data below reflect 557 patients in the main cohort with a mean duration of treatment of 33.7 weeks for the povetacicept cohort and 33.4 weeks for placebo. Adverse Events Occurring During the Treatment Period in the Safety Population: Placebo N=185 n (%) Patients with any adverse event during the treatment emergent period 145 (78.4), Povetacicept N=372 n (%) Patients with any adverse event during the treatment emergent period 279 (75.0). Adverse events occurring in =10% of patients in either group: Upper respiratory tract infection 21 (11.4) for placebo, 68 (18.3) for povetacicept; Nasopharyngitis 23 (12.4) for placebo, 36 (9.7) for povetacicept; Injection site reactions 4 (2.2) for placebo, 54 (14.5) for povetacicept. Injection site reactions (ISR) were identified using a pre-specified set of Preferred Terms (including, for example, injection site reaction and injection site erythema). All ISRs were non-serious and mild or moderate in severity. Serious AEs occurred in 4.3% (8 out of 185 patients) of the placebo group and 3.0% (11 out of 372 patients) of the povetacicept group. The same incidence of SAEs of infection (0.5%) occurred in both the placebo and povetacicept groups. The U.S. Food and Drug Administration (FDA) has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex has already submitted several modules and will complete the full BLA submission by the end of March for potential accelerated approval. Vertex is using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which promote B cell activation, differentiation and/or survival, and provides B cell control by inhibiting the ability of BAFF and APRIL to drive the pathogenesis of multiple autoimmune diseases. Due to its engineered TACI domain, povetacicept has demonstrated improved binding affinity, potency, pharmacokinetics, and/or tissue distribution compared to other APRIL, BAFF, and dual BAFF+APRIL inhibitors in preclinical studies. Povetacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN. Povetacicept is the only dual BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Expansion into additional indications for povetacicept is advancing with the ongoing Phase 2/3 OLYMPUS trial in primary membranous nephropathy (pMN) and the expected start of the ETNA Phase 2 trial in generalized myasthenia gravis (gMG) in the first half of 2026. Povetacicept is an investigational agent and has not been approved by health authorities.お知らせ • Mar 05Vertex Pharmaceuticals Incorporated Presents New Data on JOURNAVX for Effective Pain Management Following Aesthetic and Reconstructive ProceduresVertex Pharmaceuticals Incorporated announced data from a Phase 4 study of JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days. JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting. These data will be presented on March 6, 2026 during the AAPM meeting.お知らせ • Feb 13Vertex Pharmaceuticals Incorporated Provides Earnings Guidance for the Full Year 2026Vertex Pharmaceuticals Incorporated provided earnings guidance for the full year 2026. For the year, the company expects total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK; as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.お知らせ • Jan 21Vertex Pharmaceuticals Incorporated to Report Q4, 2025 Results on Feb 12, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q4, 2025 results After-Market on Feb 12, 2026お知らせ • Dec 06Vertex Pharmaceuticals Incorporated Presents New Data on CASGEVY, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory SubmissionsVertex Pharmaceuticals Incorporated announced data from multiple studies demonstrating the clinical benefits of CASGEVY®? (exagamglogene autotemcel) in people ages 5-11 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and TDT ages 12 years and older, will be presented at the American Society of Hematology (ASH) Annual Meeting. First presentation of data in children ages 5- 11 years treated with CASGEVY: In children with SCD, 11 patients have been dosed with CASGEVY in the Phase 3 CLIMB-151 clinical study, and all (4/4) patients with sufficient follow-up achieved the primary endpoint of being free from vaso-occlusive cancers (VOCs) for at least 12 consecutive months (VF12). In children with TDT, 13 patients have been dosed withASGEVY in the Phase3 CLIMB-141 clinical study, and all (6/6) patients with sufficient follow- up achieved the primary endpoint of transfusion independence for at least 12 consecutive months while maintaining a weighted average hemoglobin (Hb) of at least 9 g/dL (TI12). New longer-term data from the key clinical studies of CASGEVY in people 12 years and older will also be presented at ASH. These data, as of April 2025, continue to demonstrate the transformative, durable clinical benefits that CASGEVY provides to people living with SCD or TDT. TDT requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectations, decreased quality of life and reduced lifetime earnings and productivity. Vertex recently received a Commissioner's National Priority Voucher for CASGEVY in the 5-11 years age group from the U.S. Food and Drug Administration to accelerate the review of the sBLA once submitted. Products under the program will be subject to a 1-2-month review clock from the start of FDA's review and will also benefit from enhanced communication opportunities with the agency. The company may report side effects to FDA at 1-800-FDA-1088.お知らせ • Nov 09Vertex Presents Updated Phase 1/2 Data From RUBY-3 Study That Continue to Demonstrate Best-in-Class Potential for Povetacicept in Adults with IgA Nephropathy and Primary Membranous Nephropathy at American Society of Nephrology Kidney WeekVertex Pharmaceuticals Incorporated announced updated data for povetacicept (pove) in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) from the ongoing RUBY-3 trial at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas. Pove is an investigational recombinant fusion protein therapeutic and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Results were presented as a late-breaking oral presentation (SA-OR091) and included interim data from the open-label Phase 1/2 RUBY-3 trial, where adults with IgAN and pMN received pove subcutaneously every 4 weeks. The analysis included 21 participants with IgAN and 10 participants with pMN treated with pove at the 80mg dose, of which 17 participants and 5 participants, respectively, completed the Week 48 study visit. In IgAN, key efficacy findings for the pove 80mg cohort at 48 weeks showed a 64% decrease from baseline in mean 24-hour urine protein to creatinine ratio (UPCR), estimated glomerular filtration rate (eGFR) stabilization with change from baseline in eGFR (mean±SE) of 3.3±3.1 mL/min/1.73m, 90% (9/10) of participants achieving hematuria resolution (defined as a decrease to negative or small levels of urine blood in participants with baseline levels of urine blood of moderate or large), and 53% of participants achieving clinical remission (defined as UPCR <0.5 g/g, negative hematuria, and <25% reduction in eGFR vs. baseline). In pMN, key efficacy findings for the pove 80mg cohort at 48 weeks showed an 82% decrease from baseline in mean 24-hour UPCR, eGFR stabilization with change from baseline in eGFR (mean±SE) of -0.3±3.4 mL/min/1.73m, and 40% of participants achieving complete clinical remission (defined as UPCR <0.5 g/g). Pove was generally safe and well tolerated with adverse events (AEs) that were mostly mild or moderate in severity. There were no serious adverse events related to povetacicept. The safety data is consistent with previous interim analyses, and the safety profile is similar between the IgAN and pMN cohorts. Vertex recently announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for pove in IgAN, and the Company expects to submit the first module of the Biologics License Application (BLA) rolling submission this year for potential accelerated approval. Vertex has notified the FDA of its intent to use a priority review voucher to expedite the review of the pove BLA in IgAN from ten months to six months. The Phase 3 RAINIER study is now fully enrolled. Vertex also received Fast Track Designation from the FDA for pove in pMN, and recruitment for the pivotal Phase 2/3 OLYMPUS trial is currently underway. pMN is the second indication in which pove has demonstrated best-in-class potential.お知らせ • Nov 04Vertex Pharmaceuticals Incorporated Updates Earnings Guidance for the Fiscal Year 2025Vertex Pharmaceuticals Incorporated updated earnings guidance for the fiscal year 2025. Vertex refined its full year 2025 revenue guidance with total revenue now expected to be $11.9 to $12.0 billion, which assumes continued growth in CF, including the global launch of ALYFTREK; continued uptake of CASGEVY in multiple regions; and early contributions from the U.S. launch of JOURNAVX. the company revised Total revenue of $11.9 billion to $12.0 billion compared to previous guidance of $11.85 billion to $12.0 billion.お知らせ • Oct 18Vertex Pharmaceuticals Incorporated Announces Progress in Povetacicept Development ProgramVertex Pharmaceuticals Incorporated announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary Membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Following the announcement that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application (BLA) for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before the end of 2025. The Company remains on track to complete the full BLA submission for accelerated approval in the U.S. in the first half of 2026, if results from the planned interim analysis are supportive. The company also announced upcoming presentations at the American Society of Nephrology (ASN) Kidney Week 2025, November 6-9 in Houston, Texas highlighting data from more patients with longer duration of follow up with pove in IgAN and pMN as well as data on the burden of disease in patients with APOL1-mediated kidney disease (AMKD). Data to be Presented at ASN Vertex will present data on adults with IgAN and with pMN who received pove subcutaneously every 4 weeks (SC Fourth QuarterW) in the RUBY-3 trial, in addition to its poster presentations on inaxaplin and AMKD. A late-breaking presentation #SA-OR091, entitled "Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 weeks of Treatment: The RUBY-3 Study," will be presented during Late-Breaking Research Orals-3 session on November 8 from 5:06-5:18 p.m. CST. Final analysis will occur at two years of treatment, with a primary endpoint of portion of participants with complete clinical remission at Week 104.お知らせ • Oct 07Vertex Pharmaceuticals Incorporated to Report Q3, 2025 Results on Nov 03, 2025Vertex Pharmaceuticals Incorporated announced that they will report Q3, 2025 results After-Market on Nov 03, 2025お知らせ • Sep 25Vertex Pharmaceuticals Incorporated Announces Key Advancements Across Kidney PortfolioVertex Pharmaceuticals Incorporated announced several important advancements across its programs in immunoglobulin A Nephropathy (IgAN), APOL1-mediated kidney disease (AMKD) and autosomal dominant polycystic kidney disease (ADPKD). These updates represent significant progress toward reaching the Company's goal of bringing forward first-in-class or best-in-class therapies that target the underlying cause of these serious kidney diseases. Vertex announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to povetacicept (pove) for the treatment of IgAN. Pove is an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential in IgAN and other B cell-driven diseases. Pove is currently being studied in RAINIER, a global Phase 3 clinical trial in patients with IgAN. Inaxaplin in AMKD Vertex also announced enrollment completion of the IA cohort of AMPLITUDE, a global Phase 2/3 clinical trial designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with AMKD. The FDA's BTD is intended to expedite development and review of medicines that aim to address a serious condition with preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing treatments on one or more clinically significant endpoints. BTD was granted for pove in IgAN based on data from the Phase 2 RUBY-3 clinical trial. AMPLITUDE is a global Phase 2/3clinical trial designed to assess the impact the impact of inaxapl on kidney function and proteinuria For people living with AMKD".株主還元VRTXDAR BiotechsAR 市場7D-4.5%0%0%1Yn/a0%0%株主還元を見る業界別リターン: VRTXDがAR Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: VRTXD AR市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is VRTXD's price volatile compared to industry and market?VRTXD volatilityVRTXD Average Weekly Movement6.0%Biotechs Industry Average Movement0%Market Average Movement0%10% most volatile stocks in AR Market0%10% least volatile stocks in AR Market0%安定した株価: VRTXD 、 AR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: 過去 1 年間のVRTXDのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト19896,400Reshma Kewalramaniwww.vrtx.comヴァーテックス・ファーマシューティカルズ・インコーポレーテッドは、嚢胞性線維症（CF）治療薬の開発・商業化に携わるバイオテクノロジー企業である。同社は、少なくとも1つのF508del変異を有する2歳以上のCF患者を対象としたTRIKAFTA/KAFTRIO、6歳以上のCF患者を対象としたALYFTREK、6歳以上のCF患者を対象としたSYMDEKO/SYMKEVI、1歳以上のCF患者を対象としたORKAMBI、ivacaftorを有する1カ月以上のCF患者を対象としたKALYDECOを販売している。また、鎌状赤血球症および輸血依存性βサラセミア治療薬CASGEVY、成人の急性疼痛治療薬JOURNAVX、CFTR mRNA治療薬VX-522も開発しており、臨床第1/2相試験中である；APOL1を介した腎疾患治療薬inaxaplin（単相第2相試験中）、1型糖尿病治療薬VX-880およびVX-264、1型筋強直性ジストロフィー治療薬VX-670、常染色体優性多発性嚢胞腎治療用低分子補正薬VX-407。さらに、米国内の専門薬局や専門販売店、小売薬局、病院、診療所に製品を販売している。また、CRISPR Therapeutics社、Moderna社、Entrada Therapeutics社とも提携している。バーテックス・ファーマシューティカルズ・インコーポレーテッドは1989年に設立され、マサチューセッツ州ボストンに本社を置いている。もっと見るVertex Pharmaceuticals Incorporated 基礎のまとめVertex Pharmaceuticals の収益と売上を時価総額と比較するとどうか。VRTXD 基礎統計学時価総額US$110.23b収益（TTM）US$4.34b売上高(TTM)US$12.22b25.2xPER（株価収益率8.9xP/SレシオVRTXD 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VRTXD 損益計算書（TTM）収益US$12.22b売上原価US$5.57b売上総利益US$6.65bその他の費用US$2.31b収益US$4.34b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）17.09グロス・マージン54.39%純利益率35.51%有利子負債／自己資本比率0%VRTXD 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 15:01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Vertex Pharmaceuticals Incorporated 31 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。57 アナリスト機関Jasper HellwegArgus Research CompanyBrian SkorneyBairdEliana MerleBarclays54 その他のアナリストを表示
お知らせ • May 06Vertex Pharmaceuticals Incorporated Reaffirms Earnings Guidance for Full Year 2026Vertex Pharmaceuticals Incorporated reaffirmed earnings guidance for full year 2026. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.
お知らせ • Apr 07Vertex Pharmaceuticals Incorporated to Report Q1, 2026 Results on May 04, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 04, 2026
お知らせ • Apr 06Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026.
お知らせ • Apr 01+ 1 more updateVertex Pharmaceuticals Incorporated Announces U.S. FDA Approval of Expanded Use of ALYFTREK (Vanzacaftor/Tezacaftor/Ivacaftor)Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approximately 95% of people with CF in the U.S. are now eligible for treatment with a CFTR modulator.
お知らせ • Mar 10Vertex Pharmaceuticals Incorporated Announces Positive Interim Analysis Results for Povetacicept in Rainier Phase 3 TrialVertex Pharmaceuticals Incorporated announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001). Povetacicept was generally safe and well tolerated. RAINIER is a global Phase 3 randomized, double-blind, placebo-controlled pivotal trial of povetacicept 80 mg administered subcutaneously every four weeks versus placebo on top of standard of care. A total of 605 patients were randomized in the trial, N=557 are in the main cohort, of which N=199 are in the interim analysis population, and N=48 patients are in an exploratory cohort. These patients are representative of real world IgAN patients at risk of kidney disease progression. The median time from diagnosis of IgAN to randomization in the main cohort was approximately 3.8 years and the trial patients had high rates of background supportive care, with 97.8% of patients on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARBs), and 67.7% of patients on sodium-glucose co-transporter 2(SGLT2) inhibitors, the latter representing the highest percentage in recently completed IgAN trials. For the interim analysis, the trial’s primary endpoint is percent change from baseline in 24-hour UPCR, and the two alpha-controlled secondary endpoints are percent change from baseline in serum Gd-IgA1 and the proportion of patients to achieve hematuria resolution, all at Week 36. Exploratory endpoints for this interim analysis included the proportion of patients with 24-hour UPCR. Povetacicept was generally safe and well tolerated. The data below reflect 557 patients in the main cohort with a mean duration of treatment of 33.7 weeks for the povetacicept cohort and 33.4 weeks for placebo. Adverse Events Occurring During the Treatment Period in the Safety Population: Placebo N=185 n (%) Patients with any adverse event during the treatment emergent period 145 (78.4), Povetacicept N=372 n (%) Patients with any adverse event during the treatment emergent period 279 (75.0). Adverse events occurring in =10% of patients in either group: Upper respiratory tract infection 21 (11.4) for placebo, 68 (18.3) for povetacicept; Nasopharyngitis 23 (12.4) for placebo, 36 (9.7) for povetacicept; Injection site reactions 4 (2.2) for placebo, 54 (14.5) for povetacicept. Injection site reactions (ISR) were identified using a pre-specified set of Preferred Terms (including, for example, injection site reaction and injection site erythema). All ISRs were non-serious and mild or moderate in severity. Serious AEs occurred in 4.3% (8 out of 185 patients) of the placebo group and 3.0% (11 out of 372 patients) of the povetacicept group. The same incidence of SAEs of infection (0.5%) occurred in both the placebo and povetacicept groups. The U.S. Food and Drug Administration (FDA) has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex has already submitted several modules and will complete the full BLA submission by the end of March for potential accelerated approval. Vertex is using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which promote B cell activation, differentiation and/or survival, and provides B cell control by inhibiting the ability of BAFF and APRIL to drive the pathogenesis of multiple autoimmune diseases. Due to its engineered TACI domain, povetacicept has demonstrated improved binding affinity, potency, pharmacokinetics, and/or tissue distribution compared to other APRIL, BAFF, and dual BAFF+APRIL inhibitors in preclinical studies. Povetacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN. Povetacicept is the only dual BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Expansion into additional indications for povetacicept is advancing with the ongoing Phase 2/3 OLYMPUS trial in primary membranous nephropathy (pMN) and the expected start of the ETNA Phase 2 trial in generalized myasthenia gravis (gMG) in the first half of 2026. Povetacicept is an investigational agent and has not been approved by health authorities.
お知らせ • Mar 05Vertex Pharmaceuticals Incorporated Presents New Data on JOURNAVX for Effective Pain Management Following Aesthetic and Reconstructive ProceduresVertex Pharmaceuticals Incorporated announced data from a Phase 4 study of JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days. JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting. These data will be presented on March 6, 2026 during the AAPM meeting.
お知らせ • May 06Vertex Pharmaceuticals Incorporated Reaffirms Earnings Guidance for Full Year 2026Vertex Pharmaceuticals Incorporated reaffirmed earnings guidance for full year 2026. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.
お知らせ • Apr 07Vertex Pharmaceuticals Incorporated to Report Q1, 2026 Results on May 04, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 04, 2026
お知らせ • Apr 06Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026.
お知らせ • Apr 01+ 1 more updateVertex Pharmaceuticals Incorporated Announces U.S. FDA Approval of Expanded Use of ALYFTREK (Vanzacaftor/Tezacaftor/Ivacaftor)Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approximately 95% of people with CF in the U.S. are now eligible for treatment with a CFTR modulator.
お知らせ • Mar 10Vertex Pharmaceuticals Incorporated Announces Positive Interim Analysis Results for Povetacicept in Rainier Phase 3 TrialVertex Pharmaceuticals Incorporated announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001). Povetacicept was generally safe and well tolerated. RAINIER is a global Phase 3 randomized, double-blind, placebo-controlled pivotal trial of povetacicept 80 mg administered subcutaneously every four weeks versus placebo on top of standard of care. A total of 605 patients were randomized in the trial, N=557 are in the main cohort, of which N=199 are in the interim analysis population, and N=48 patients are in an exploratory cohort. These patients are representative of real world IgAN patients at risk of kidney disease progression. The median time from diagnosis of IgAN to randomization in the main cohort was approximately 3.8 years and the trial patients had high rates of background supportive care, with 97.8% of patients on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARBs), and 67.7% of patients on sodium-glucose co-transporter 2(SGLT2) inhibitors, the latter representing the highest percentage in recently completed IgAN trials. For the interim analysis, the trial’s primary endpoint is percent change from baseline in 24-hour UPCR, and the two alpha-controlled secondary endpoints are percent change from baseline in serum Gd-IgA1 and the proportion of patients to achieve hematuria resolution, all at Week 36. Exploratory endpoints for this interim analysis included the proportion of patients with 24-hour UPCR. Povetacicept was generally safe and well tolerated. The data below reflect 557 patients in the main cohort with a mean duration of treatment of 33.7 weeks for the povetacicept cohort and 33.4 weeks for placebo. Adverse Events Occurring During the Treatment Period in the Safety Population: Placebo N=185 n (%) Patients with any adverse event during the treatment emergent period 145 (78.4), Povetacicept N=372 n (%) Patients with any adverse event during the treatment emergent period 279 (75.0). Adverse events occurring in =10% of patients in either group: Upper respiratory tract infection 21 (11.4) for placebo, 68 (18.3) for povetacicept; Nasopharyngitis 23 (12.4) for placebo, 36 (9.7) for povetacicept; Injection site reactions 4 (2.2) for placebo, 54 (14.5) for povetacicept. Injection site reactions (ISR) were identified using a pre-specified set of Preferred Terms (including, for example, injection site reaction and injection site erythema). All ISRs were non-serious and mild or moderate in severity. Serious AEs occurred in 4.3% (8 out of 185 patients) of the placebo group and 3.0% (11 out of 372 patients) of the povetacicept group. The same incidence of SAEs of infection (0.5%) occurred in both the placebo and povetacicept groups. The U.S. Food and Drug Administration (FDA) has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex has already submitted several modules and will complete the full BLA submission by the end of March for potential accelerated approval. Vertex is using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which promote B cell activation, differentiation and/or survival, and provides B cell control by inhibiting the ability of BAFF and APRIL to drive the pathogenesis of multiple autoimmune diseases. Due to its engineered TACI domain, povetacicept has demonstrated improved binding affinity, potency, pharmacokinetics, and/or tissue distribution compared to other APRIL, BAFF, and dual BAFF+APRIL inhibitors in preclinical studies. Povetacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN. Povetacicept is the only dual BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Expansion into additional indications for povetacicept is advancing with the ongoing Phase 2/3 OLYMPUS trial in primary membranous nephropathy (pMN) and the expected start of the ETNA Phase 2 trial in generalized myasthenia gravis (gMG) in the first half of 2026. Povetacicept is an investigational agent and has not been approved by health authorities.
お知らせ • Mar 05Vertex Pharmaceuticals Incorporated Presents New Data on JOURNAVX for Effective Pain Management Following Aesthetic and Reconstructive ProceduresVertex Pharmaceuticals Incorporated announced data from a Phase 4 study of JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days. JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting. These data will be presented on March 6, 2026 during the AAPM meeting.
お知らせ • Feb 13Vertex Pharmaceuticals Incorporated Provides Earnings Guidance for the Full Year 2026Vertex Pharmaceuticals Incorporated provided earnings guidance for the full year 2026. For the year, the company expects total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK; as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX.
お知らせ • Jan 21Vertex Pharmaceuticals Incorporated to Report Q4, 2025 Results on Feb 12, 2026Vertex Pharmaceuticals Incorporated announced that they will report Q4, 2025 results After-Market on Feb 12, 2026
お知らせ • Dec 06Vertex Pharmaceuticals Incorporated Presents New Data on CASGEVY, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory SubmissionsVertex Pharmaceuticals Incorporated announced data from multiple studies demonstrating the clinical benefits of CASGEVY®? (exagamglogene autotemcel) in people ages 5-11 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and TDT ages 12 years and older, will be presented at the American Society of Hematology (ASH) Annual Meeting. First presentation of data in children ages 5- 11 years treated with CASGEVY: In children with SCD, 11 patients have been dosed with CASGEVY in the Phase 3 CLIMB-151 clinical study, and all (4/4) patients with sufficient follow-up achieved the primary endpoint of being free from vaso-occlusive cancers (VOCs) for at least 12 consecutive months (VF12). In children with TDT, 13 patients have been dosed withASGEVY in the Phase3 CLIMB-141 clinical study, and all (6/6) patients with sufficient follow- up achieved the primary endpoint of transfusion independence for at least 12 consecutive months while maintaining a weighted average hemoglobin (Hb) of at least 9 g/dL (TI12). New longer-term data from the key clinical studies of CASGEVY in people 12 years and older will also be presented at ASH. These data, as of April 2025, continue to demonstrate the transformative, durable clinical benefits that CASGEVY provides to people living with SCD or TDT. TDT requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectations, decreased quality of life and reduced lifetime earnings and productivity. Vertex recently received a Commissioner's National Priority Voucher for CASGEVY in the 5-11 years age group from the U.S. Food and Drug Administration to accelerate the review of the sBLA once submitted. Products under the program will be subject to a 1-2-month review clock from the start of FDA's review and will also benefit from enhanced communication opportunities with the agency. The company may report side effects to FDA at 1-800-FDA-1088.
お知らせ • Nov 09Vertex Presents Updated Phase 1/2 Data From RUBY-3 Study That Continue to Demonstrate Best-in-Class Potential for Povetacicept in Adults with IgA Nephropathy and Primary Membranous Nephropathy at American Society of Nephrology Kidney WeekVertex Pharmaceuticals Incorporated announced updated data for povetacicept (pove) in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) from the ongoing RUBY-3 trial at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas. Pove is an investigational recombinant fusion protein therapeutic and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Results were presented as a late-breaking oral presentation (SA-OR091) and included interim data from the open-label Phase 1/2 RUBY-3 trial, where adults with IgAN and pMN received pove subcutaneously every 4 weeks. The analysis included 21 participants with IgAN and 10 participants with pMN treated with pove at the 80mg dose, of which 17 participants and 5 participants, respectively, completed the Week 48 study visit. In IgAN, key efficacy findings for the pove 80mg cohort at 48 weeks showed a 64% decrease from baseline in mean 24-hour urine protein to creatinine ratio (UPCR), estimated glomerular filtration rate (eGFR) stabilization with change from baseline in eGFR (mean±SE) of 3.3±3.1 mL/min/1.73m, 90% (9/10) of participants achieving hematuria resolution (defined as a decrease to negative or small levels of urine blood in participants with baseline levels of urine blood of moderate or large), and 53% of participants achieving clinical remission (defined as UPCR <0.5 g/g, negative hematuria, and <25% reduction in eGFR vs. baseline). In pMN, key efficacy findings for the pove 80mg cohort at 48 weeks showed an 82% decrease from baseline in mean 24-hour UPCR, eGFR stabilization with change from baseline in eGFR (mean±SE) of -0.3±3.4 mL/min/1.73m, and 40% of participants achieving complete clinical remission (defined as UPCR <0.5 g/g). Pove was generally safe and well tolerated with adverse events (AEs) that were mostly mild or moderate in severity. There were no serious adverse events related to povetacicept. The safety data is consistent with previous interim analyses, and the safety profile is similar between the IgAN and pMN cohorts. Vertex recently announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for pove in IgAN, and the Company expects to submit the first module of the Biologics License Application (BLA) rolling submission this year for potential accelerated approval. Vertex has notified the FDA of its intent to use a priority review voucher to expedite the review of the pove BLA in IgAN from ten months to six months. The Phase 3 RAINIER study is now fully enrolled. Vertex also received Fast Track Designation from the FDA for pove in pMN, and recruitment for the pivotal Phase 2/3 OLYMPUS trial is currently underway. pMN is the second indication in which pove has demonstrated best-in-class potential.
お知らせ • Nov 04Vertex Pharmaceuticals Incorporated Updates Earnings Guidance for the Fiscal Year 2025Vertex Pharmaceuticals Incorporated updated earnings guidance for the fiscal year 2025. Vertex refined its full year 2025 revenue guidance with total revenue now expected to be $11.9 to $12.0 billion, which assumes continued growth in CF, including the global launch of ALYFTREK; continued uptake of CASGEVY in multiple regions; and early contributions from the U.S. launch of JOURNAVX. the company revised Total revenue of $11.9 billion to $12.0 billion compared to previous guidance of $11.85 billion to $12.0 billion.
お知らせ • Oct 18Vertex Pharmaceuticals Incorporated Announces Progress in Povetacicept Development ProgramVertex Pharmaceuticals Incorporated announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary Membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Following the announcement that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application (BLA) for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before the end of 2025. The Company remains on track to complete the full BLA submission for accelerated approval in the U.S. in the first half of 2026, if results from the planned interim analysis are supportive. The company also announced upcoming presentations at the American Society of Nephrology (ASN) Kidney Week 2025, November 6-9 in Houston, Texas highlighting data from more patients with longer duration of follow up with pove in IgAN and pMN as well as data on the burden of disease in patients with APOL1-mediated kidney disease (AMKD). Data to be Presented at ASN Vertex will present data on adults with IgAN and with pMN who received pove subcutaneously every 4 weeks (SC Fourth QuarterW) in the RUBY-3 trial, in addition to its poster presentations on inaxaplin and AMKD. A late-breaking presentation #SA-OR091, entitled "Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 weeks of Treatment: The RUBY-3 Study," will be presented during Late-Breaking Research Orals-3 session on November 8 from 5:06-5:18 p.m. CST. Final analysis will occur at two years of treatment, with a primary endpoint of portion of participants with complete clinical remission at Week 104.
お知らせ • Oct 07Vertex Pharmaceuticals Incorporated to Report Q3, 2025 Results on Nov 03, 2025Vertex Pharmaceuticals Incorporated announced that they will report Q3, 2025 results After-Market on Nov 03, 2025
お知らせ • Sep 25Vertex Pharmaceuticals Incorporated Announces Key Advancements Across Kidney PortfolioVertex Pharmaceuticals Incorporated announced several important advancements across its programs in immunoglobulin A Nephropathy (IgAN), APOL1-mediated kidney disease (AMKD) and autosomal dominant polycystic kidney disease (ADPKD). These updates represent significant progress toward reaching the Company's goal of bringing forward first-in-class or best-in-class therapies that target the underlying cause of these serious kidney diseases. Vertex announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to povetacicept (pove) for the treatment of IgAN. Pove is an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential in IgAN and other B cell-driven diseases. Pove is currently being studied in RAINIER, a global Phase 3 clinical trial in patients with IgAN. Inaxaplin in AMKD Vertex also announced enrollment completion of the IA cohort of AMPLITUDE, a global Phase 2/3 clinical trial designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with AMKD. The FDA's BTD is intended to expedite development and review of medicines that aim to address a serious condition with preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing treatments on one or more clinically significant endpoints. BTD was granted for pove in IgAN based on data from the Phase 2 RUBY-3 clinical trial. AMPLITUDE is a global Phase 2/3clinical trial designed to assess the impact the impact of inaxapl on kidney function and proteinuria For people living with AMKD".
