View ValuationSionna Therapeutics 将来の成長Future 基準チェック /26Sionna Therapeuticsの収益は年間12.5%で減少すると予測されていますが、年間収益は年間71.2%で増加すると予測されています。EPS は年間 減少すると予測されています。自己資本利益率は 3 年後に-41% 5.7%なると予測されています。主要情報-12.5%収益成長率-5.73%EPS成長率Biotechs 収益成長25.3%収益成長率71.2%将来の株主資本利益率-40.97%アナリストカバレッジGood最終更新日20 May 2026今後の成長に関する最新情報更新なしすべての更新を表示Recent updatesライブニュース • May 14Sionna Therapeutics Eyes Key 2026 Trial Results With Strong Cash and Analyst SupportSionna Therapeutics completed enrollment in its Phase 2a PreciSION CF trial evaluating NBD1 stabilizer SION-719 as an add-on therapy for cystic fibrosis, with topline data from this study and a Phase 1 dual-combination trial with SION-451 expected in summer 2026. The company reported a Q1 2026 net loss of $26.8 million, or $0.60 per share, and held cash and equivalents of $289.9 million, which management projects is sufficient to fund operations into 2028. Director Peter Thompson and OrbiMed Advisors each sold roughly $13.3 million of Sionna stock under pre-arranged trading plans, while several research firms reiterated positive ratings and price targets up to $53 following the earnings update and trial progress. The key swing factor for Sionna over the next two years is the paired readout from SION-719 and the SION-719 / SION-451 combination. These data could materially influence how the pipeline and funding runway are perceived. Insider sales under trading plans do not automatically signal a change in company fundamentals. However, they are worth tracking alongside clinical milestones and cash usage as you assess risk and potential dilution over time.お知らせ • Apr 30Sionna Therapeutics Inc Completes Enrollment in Precision Cf Phase 2A Trial Evaluating Nbd1 Stabilizer Sion-719 Added to Standard of Care in Participants with Cystic FibrosisSionna Therapeutics, Inc. announced the completion of enrollment in the PreciSION CF Phase 2a proof-of-concept (POC) trial. This trial is evaluating SION-719, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, when added to Trikafta (elexacaftor/tezacaftor/ivacaftor), the current standard of care (SOC) in CF. Sionna anticipates data from the PreciSION CF trial in the summer of 2026. The PreciSION CF Phase 2a trial (NCT07108153) is a randomized, double-blind, placebo-controlled, crossover POC study that enrolled adult CF patients homozygous for F508del on a stable dose of physician-prescribed Trikafta. The objectives of the trial are to evaluate the safety, tolerability, and pharmacokinetics of SION-719 when administered with SOC and to assess change in sweat chloride levels, an important measure of CFTR function. The PreciSION CF trial is being conducted at multiple sites, including sites in the CF Foundation-supported Therapeutics Development Network (TDN), the largest CF clinical trials network in the world.お知らせ • Apr 29Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026.Seeking Alpha • Nov 07Sionna Therapeutics Q3 2025: Advancing CF Pipeline Toward Proof-Of-ConceptSummary Sionna Therapeutics reported a narrowed GAAP EPS loss and maintains a strong $325M cash position, funding operations through 2028. SION advanced its cystic fibrosis pipeline, launching Phase 2a for SION-719 and Phase 1 for SION-451, with topline data expected mid-2026. The stock has surged 44% since the previous buy call, driven by pipeline momentum and investor confidence in its NBD1 stabiliser programs. Despite the recent pullback from $42 to $35, SION presents continued upside potential ahead of key clinical catalysts in 2026. Read the full article on Seeking Alphaお知らせ • Oct 25Sionna Therapeutics Announces Presentation of SION-719 and SION-451 Phase 1 Data and Poster of New Preclinical Data on the Impact of NBD1 Stabilizer on F508del-CFTR Half-Life at the 2025 North American Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced data presented at the 2025 North American Cystic Fibrosis Conference (NACFC) being held in Seattle, Washingt on October 22-25. Jason H. Maley, M.D., MS, Senior Director of Clinical Development at Sionna, presented data from the two Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers. The randomized, double-blind, placebo-controlled Phase 1 trials enrolled over 200 healthy volunteers and evaluated each compound's safety, tolerability, and pharmacokinetics (PK) across single and multiple ascending dose cohorts. As previously disclosed, Sionna's two Phase 1 trials demonstrated that both SION-719 andSION-451 were generally well tolerated and exceeded target exposure levels. Based on these Phase 1 data and its cystic fibrosis human bronchial epithelial (CFHBE) model, Sionna believes that its NBD1 stabilizers have the potential to deliver clinically meaningful benefit when SION-719 is added to the standard of care (SOC) or when SION-451 is used in proprietary dual combinations with one of Sionna's complementary modulators. The Phase 1 data also supported the use of a tablet formulation in future trials and indicated that both compounds can be dosed in a fed or fast state. In a poster presented by Greg Hurlbut, Ph.D., Co-Founder and Senior Vice President of Discovery Research at Sionna, new preclinical data from metabolic pulse-chase labeling studies show the impact of Sionna's NBD1 stabilizers on the half-life of F508del-CFTR protein, in the presence and absence of Sionna's complementary CFTR modulators. In these studies, NBD1 stabilizers SION-719 and NBD1 stabilizers Sionna-719 and SION -451 increased the half-life of mature F508del-CFTR proteins to levels seen with wild-type CFTR. This effect was apparent even when NBD1 stabilizers were used as single agents. The most common CFTR mutation that causes CF is F508del, which results in the instability of CFTR's NBD1 domain and impaired CFTR folding, trafficking, half-life, and function," said Dr. Hurlbut. The minimal amount of F508del-CF TR protein that does reach the apical cellular membrane exhibits a dramatically increased rate ofdegradation and decreased half-life relative to wild-type CFTR. The company have previously previously announced that the NBD1 stabilizers are currently being evaluated in the Phase 1 data in the clinical trial.お知らせ • Sep 09Sionna Therapeutics, Inc Appoints Caroline Stark Beer as Chief Business OfficerSionna Therapeutics, Inc. announced the appointment of Caroline Stark Beer, MBA, as its Chief Business Officer (CBO). Caroline brings over 20 years of experience in the life science industry to her role with Sionna. She was most recently CBO at Jnana Therapeutics until Jnanas sale to Otsuka Pharmaceutical. Caroline led the team responsible for corporate and business development, alliance management, legal contracts, new product planning, and communications. Before Jnana, she spent over a decade at Alnylam Pharmaceuticals; in her final role there, she served as VP of Business Development. During this time, she led the formation of a variety of high-impact partnerships including a 5-year collaboration with Regeneron Pharmaceuticals to discover and develop new RNA interference (RNAi) therapeutics. Prior to Alnylam, Caroline served in business development at Amicus Therapeutics and started her career as a strategy consultant at Bain &Company. Caroline received her MBA from the MIT Sloan School of Management and a Bachelor of Economics from Duke University.お知らせ • Aug 25Sionna Therapeutics Announces First Subjects Dosed in Phase 1 Trial Evaluating NBD1 Stabilizer, SION-451, in Proprietary Dual Combinations in Development for the Treatment of Cystic FibrosisSionna Therapeutics, Inc. announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intrracellular loop 4 (ICL4)-directed CFTR corrector. This Phase 1 trial is a randomized, double-blind, placebo-controlled trial in healthy volunteers. It is designed to assess the safety, tolerability, and pharmacokinetics (PK) of varying doses of dual combinations of SION-2222 and SION-109 with SION-109. Topline data are anticipated in mid-2026, and will inform selection of a dual combination for a planned Phase 2b trial in people living with CF. CF is a progressive and life-threatening genetic disease that affects more than 100,000 people globally. While advances in the discovery and development of modulators have significantly improved the lives of people living with CF, at least two-thirds of patients on the current standard of care do not have normal CFTR function as measured by levels of sweat chloride. The NBD1 domain of the CFTR protein plays a critical role in the folding, stability and trafficking of CFTR to a cell's surface, but no approved CF therapies directly stabilize NBD1. Positive data from Phase 1 clinical trials and preclinical data support the mechanistic rationale and advancement of this dual combination trial. In its recent Phase 1 trial, SION-451 was generally well tolerated and exceeded PK concentration targets that Sionna believes, based on its preclinical CF human bronchialhelial (CFHBE) model, indicate the potential to provide clinically meaningful benefit, including the potential for wild-type levels of CFTR function, in proprietary dual combinations with complementary modulators.分析記事 • Aug 24Here's Why We're Not Too Worried About Sionna Therapeutics' (NASDAQ:SION) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...お知らせ • Jun 18Sling Therapeutics, Inc. Appoints Ken Lock as Chief Commercial OfficerSling Therapeutics, Inc. announced the appointment of Ken Lock as Chief Commercial Officer. Lock brings over 20 years of commercial leadership experience as Sling prepares for a confirmatory Phase 3 study of linsitinib. Most recently, Lock served as Chief Commercial Officer at ACELYRIN, where he led the commercial, medical affairs, and alliance management functions in the TED market. Lock also served as Chief Commercial Officer at Arcutis Biotherapeutics, where he built and led a team of over 130 people and was responsible for the launch and brand development of ZORYVE®. Prior to that, he held sales and marketing roles of increasing responsibility at Gilead Sciences, Amgen, and Wyeth (now Pfizer). Lock holds an M.B.A. from the Cornell Johnson Graduate School of Management and a dual B.S. and B.A. in Biochemistry/Cell Biology and Psychology from the University of California, San Diego.お知らせ • Jun 07Sionna Therapeutics, Inc. Announces Presentation of Preclinical Data That Demonstrate Proprietary Dual Combination Therapies Enable Full CFTR Correction in CFHBE ModelSionna Therapeutics, Inc. announced the presentation of preclinical data that demonstrate that the company's nucleotide-binding domain 1 (NBD1) stabilizers, in dual combinations with proprietary complementary modulators, enable full CFTR correction in CF models. The data are featured in an oral presentation and poster session at the European Cystic Fibrosis Society (ECFS) 48thEuropean Cystic Fibrosis Conference being held in Milan, Italy. Preclinical data suggest these compounds, when used in combination, have the potential to dramatically improve clinical outcomes and quality of life for people with CF." Sionna has completed Phase 1 clinical trials evaluating two potent first-in-class small molecule NBD1 stabilizers, SION-719 and SION-451. The company is also developing modulators with mechanisms of action that are complementary to NBD1, including SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. In the CFHBE model, SION-719 & SION-451 dual combinations also show potential for clinically meaningful improvement including to wild-type levels at concentrations below Emax. Earlier this week, Sionna announced its plans to advance SION-719 andSION-451 to the next stage of clinical development. The company plans to evaluate SION-719 in a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to standard of care (SOC), and SION-451 in a Phase 1 healthy volunteer trial evaluating SION-451 in two dual combinations with SION-2222 and with SION-109. Both trials are expected to initiate in the second half of 2025, with data anticipated in mid-2026.お知らせ • Jun 04Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic FibrosisSionna Therapeutics, Inc. announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers. Sionna plans to advance both NBD1 stabilizers to the next stage of clinical development -- SION-719 to a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to SOC, and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719, and SION-451 in healthy volunteers. SionNA is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add- on to SOC and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. Positive Phase 1 Results for SION-719 and SION-451: The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719 and SION-451 in healthy volunteers. The effect of food on the PK and the bioequivalence of a tablet formulation was also evaluated in Part C of each trial. 100 subjects were dosed in the SION-719 trial and 110 subjects were dosed in the SION-451 trial. Both compounds were generally well tolerated in the Phase 1 trials. There were no serious adverse events, treatment emergent adverse events (TEAEs) that led to discontinuation of drug, or dose-limiting TEAEs observed. Most TEAEs were mild to moderate (Grade 1 or Grade 2). There was one Grade 1 TEAE related to liver function tests (LFTs) in a SION-451 treated subject who tested positive for influenza; no TEAEs related to LFTs were observed in the other cohorts of SION-451. There were no TEAEs related to LFTs in SION-719 treated subjects. The data from Part C of each trial support the use of a tablet formulation in future studies and indicate that both compounds can be dosed in a fed or fasted state. SION-719 and SION-451 each achieved desired target PK concentrations at multiple dose levels in a twice daily regimen. Both stabilizers met exposure thresholds that, based on Sionna’s preclinical CFHBE model, have the potential to provide clinically meaningful benefit if administered as an add-on to SOC or in a proprietary dual combination with complementary modulators. Next Phase of Clinical Development for NBD1 Stabilizers: SION-719 to Advance to Phase 2a Proof-of-concept in CF Patients as an Add-on to Standard of Care: Sionna is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add-on to SOC in CF patients. The trial objectives will be to show an improvement in CFTR function as defined by sweat chloride reduction and to demonstrate that NBD1 is mechanistically unique from, and synergistic with, the components of SOC. Sionna is on track to initiate this trial in the second half of 2025 with topline data anticipated in mid-2026. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SION-719, and the first subject has been dosed in a midazolam drug-drug interaction (DDI) study to confirm SION-719 can be dosed in combination with the SOC according to its label. This study will be completed prior to initiation of the Phase 2a trial. SION-451 to Advance to Phase 1 Healthy Volunteer Dual Combination Trial with Complementary Modulators: Sionna plans to initiate a Phase 1 healthy volunteer dual combination trial evaluating SION-451 in combination with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. The trial will assess the safety, tolerability, and PK of varying doses of the dual combinations, and will inform selection of a dual combination for a Phase 2b trial in CF patients. Sionna is on track to initiate the healthy volunteer trial in the second half of 2025 with topline data expected in mid-2026.お知らせ • May 22Sionna Therapeutics to Present Preclinical Data During Oral Session At the 48Th European Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced that preclinical data assessing combinations of Sionna's nucleotide-binding domain 1 (NBD1) stabilizers, SION-451 and SION-719, with complementary Sionna CFTR modulators, galicaftor (SION-2222) and SION-109, will be featured in an oral presentation at the European Cystic Fibrosis Society's (ECFS) 48thEuropean Cystic Fibrosis Conference, being held June 4-7, 2025 in Milan, Italy.お知らせ • Apr 30Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025.お知らせ • Feb 07Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million.Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,588,233 Price\Range: $18 Transaction Features: Sponsor Backed Offering業績と収益の成長予測NasdaqGM:SION - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20283-163-128-147912/31/20273-138-119-1121012/31/2026N/A-119-114-106103/31/2026N/A-86-72-72N/A12/31/2025N/A-75-67-66N/A9/30/2025N/A-71-62-61N/A6/30/2025N/A-76-64-64N/A3/31/2025N/A-66-56-56N/A12/31/2024N/A-62-53-53N/A9/30/2024N/A-58-49-48N/A12/31/2023N/A-47-45-44N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: SION今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: SION今後 3 年間、利益が出ない状態が続くと予測されています。高成長収益: SION今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: SIONの収益 ( 71.2% ) US市場 ( 11.7% ) よりも速いペースで成長すると予測されています。高い収益成長: SIONの収益 ( 71.2% ) 20%よりも速いペースで成長すると予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: SION 3 年以内に赤字になると予測されています。成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance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2026/05/22 20:48終値2026/05/22 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Sionna Therapeutics, Inc. 10 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。12 アナリスト機関Kambiz YazdiBTIGJonathan WollebenCitizens JMP Securities, LLCIlya ZubkovFreedom Broker9 その他のアナリストを表示
ライブニュース • May 14Sionna Therapeutics Eyes Key 2026 Trial Results With Strong Cash and Analyst SupportSionna Therapeutics completed enrollment in its Phase 2a PreciSION CF trial evaluating NBD1 stabilizer SION-719 as an add-on therapy for cystic fibrosis, with topline data from this study and a Phase 1 dual-combination trial with SION-451 expected in summer 2026. The company reported a Q1 2026 net loss of $26.8 million, or $0.60 per share, and held cash and equivalents of $289.9 million, which management projects is sufficient to fund operations into 2028. Director Peter Thompson and OrbiMed Advisors each sold roughly $13.3 million of Sionna stock under pre-arranged trading plans, while several research firms reiterated positive ratings and price targets up to $53 following the earnings update and trial progress. The key swing factor for Sionna over the next two years is the paired readout from SION-719 and the SION-719 / SION-451 combination. These data could materially influence how the pipeline and funding runway are perceived. Insider sales under trading plans do not automatically signal a change in company fundamentals. However, they are worth tracking alongside clinical milestones and cash usage as you assess risk and potential dilution over time.
お知らせ • Apr 30Sionna Therapeutics Inc Completes Enrollment in Precision Cf Phase 2A Trial Evaluating Nbd1 Stabilizer Sion-719 Added to Standard of Care in Participants with Cystic FibrosisSionna Therapeutics, Inc. announced the completion of enrollment in the PreciSION CF Phase 2a proof-of-concept (POC) trial. This trial is evaluating SION-719, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, when added to Trikafta (elexacaftor/tezacaftor/ivacaftor), the current standard of care (SOC) in CF. Sionna anticipates data from the PreciSION CF trial in the summer of 2026. The PreciSION CF Phase 2a trial (NCT07108153) is a randomized, double-blind, placebo-controlled, crossover POC study that enrolled adult CF patients homozygous for F508del on a stable dose of physician-prescribed Trikafta. The objectives of the trial are to evaluate the safety, tolerability, and pharmacokinetics of SION-719 when administered with SOC and to assess change in sweat chloride levels, an important measure of CFTR function. The PreciSION CF trial is being conducted at multiple sites, including sites in the CF Foundation-supported Therapeutics Development Network (TDN), the largest CF clinical trials network in the world.
お知らせ • Apr 29Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026.
Seeking Alpha • Nov 07Sionna Therapeutics Q3 2025: Advancing CF Pipeline Toward Proof-Of-ConceptSummary Sionna Therapeutics reported a narrowed GAAP EPS loss and maintains a strong $325M cash position, funding operations through 2028. SION advanced its cystic fibrosis pipeline, launching Phase 2a for SION-719 and Phase 1 for SION-451, with topline data expected mid-2026. The stock has surged 44% since the previous buy call, driven by pipeline momentum and investor confidence in its NBD1 stabiliser programs. Despite the recent pullback from $42 to $35, SION presents continued upside potential ahead of key clinical catalysts in 2026. Read the full article on Seeking Alpha
お知らせ • Oct 25Sionna Therapeutics Announces Presentation of SION-719 and SION-451 Phase 1 Data and Poster of New Preclinical Data on the Impact of NBD1 Stabilizer on F508del-CFTR Half-Life at the 2025 North American Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced data presented at the 2025 North American Cystic Fibrosis Conference (NACFC) being held in Seattle, Washingt on October 22-25. Jason H. Maley, M.D., MS, Senior Director of Clinical Development at Sionna, presented data from the two Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers. The randomized, double-blind, placebo-controlled Phase 1 trials enrolled over 200 healthy volunteers and evaluated each compound's safety, tolerability, and pharmacokinetics (PK) across single and multiple ascending dose cohorts. As previously disclosed, Sionna's two Phase 1 trials demonstrated that both SION-719 andSION-451 were generally well tolerated and exceeded target exposure levels. Based on these Phase 1 data and its cystic fibrosis human bronchial epithelial (CFHBE) model, Sionna believes that its NBD1 stabilizers have the potential to deliver clinically meaningful benefit when SION-719 is added to the standard of care (SOC) or when SION-451 is used in proprietary dual combinations with one of Sionna's complementary modulators. The Phase 1 data also supported the use of a tablet formulation in future trials and indicated that both compounds can be dosed in a fed or fast state. In a poster presented by Greg Hurlbut, Ph.D., Co-Founder and Senior Vice President of Discovery Research at Sionna, new preclinical data from metabolic pulse-chase labeling studies show the impact of Sionna's NBD1 stabilizers on the half-life of F508del-CFTR protein, in the presence and absence of Sionna's complementary CFTR modulators. In these studies, NBD1 stabilizers SION-719 and NBD1 stabilizers Sionna-719 and SION -451 increased the half-life of mature F508del-CFTR proteins to levels seen with wild-type CFTR. This effect was apparent even when NBD1 stabilizers were used as single agents. The most common CFTR mutation that causes CF is F508del, which results in the instability of CFTR's NBD1 domain and impaired CFTR folding, trafficking, half-life, and function," said Dr. Hurlbut. The minimal amount of F508del-CF TR protein that does reach the apical cellular membrane exhibits a dramatically increased rate ofdegradation and decreased half-life relative to wild-type CFTR. The company have previously previously announced that the NBD1 stabilizers are currently being evaluated in the Phase 1 data in the clinical trial.
お知らせ • Sep 09Sionna Therapeutics, Inc Appoints Caroline Stark Beer as Chief Business OfficerSionna Therapeutics, Inc. announced the appointment of Caroline Stark Beer, MBA, as its Chief Business Officer (CBO). Caroline brings over 20 years of experience in the life science industry to her role with Sionna. She was most recently CBO at Jnana Therapeutics until Jnanas sale to Otsuka Pharmaceutical. Caroline led the team responsible for corporate and business development, alliance management, legal contracts, new product planning, and communications. Before Jnana, she spent over a decade at Alnylam Pharmaceuticals; in her final role there, she served as VP of Business Development. During this time, she led the formation of a variety of high-impact partnerships including a 5-year collaboration with Regeneron Pharmaceuticals to discover and develop new RNA interference (RNAi) therapeutics. Prior to Alnylam, Caroline served in business development at Amicus Therapeutics and started her career as a strategy consultant at Bain &Company. Caroline received her MBA from the MIT Sloan School of Management and a Bachelor of Economics from Duke University.
お知らせ • Aug 25Sionna Therapeutics Announces First Subjects Dosed in Phase 1 Trial Evaluating NBD1 Stabilizer, SION-451, in Proprietary Dual Combinations in Development for the Treatment of Cystic FibrosisSionna Therapeutics, Inc. announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intrracellular loop 4 (ICL4)-directed CFTR corrector. This Phase 1 trial is a randomized, double-blind, placebo-controlled trial in healthy volunteers. It is designed to assess the safety, tolerability, and pharmacokinetics (PK) of varying doses of dual combinations of SION-2222 and SION-109 with SION-109. Topline data are anticipated in mid-2026, and will inform selection of a dual combination for a planned Phase 2b trial in people living with CF. CF is a progressive and life-threatening genetic disease that affects more than 100,000 people globally. While advances in the discovery and development of modulators have significantly improved the lives of people living with CF, at least two-thirds of patients on the current standard of care do not have normal CFTR function as measured by levels of sweat chloride. The NBD1 domain of the CFTR protein plays a critical role in the folding, stability and trafficking of CFTR to a cell's surface, but no approved CF therapies directly stabilize NBD1. Positive data from Phase 1 clinical trials and preclinical data support the mechanistic rationale and advancement of this dual combination trial. In its recent Phase 1 trial, SION-451 was generally well tolerated and exceeded PK concentration targets that Sionna believes, based on its preclinical CF human bronchialhelial (CFHBE) model, indicate the potential to provide clinically meaningful benefit, including the potential for wild-type levels of CFTR function, in proprietary dual combinations with complementary modulators.
分析記事 • Aug 24Here's Why We're Not Too Worried About Sionna Therapeutics' (NASDAQ:SION) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
お知らせ • Jun 18Sling Therapeutics, Inc. Appoints Ken Lock as Chief Commercial OfficerSling Therapeutics, Inc. announced the appointment of Ken Lock as Chief Commercial Officer. Lock brings over 20 years of commercial leadership experience as Sling prepares for a confirmatory Phase 3 study of linsitinib. Most recently, Lock served as Chief Commercial Officer at ACELYRIN, where he led the commercial, medical affairs, and alliance management functions in the TED market. Lock also served as Chief Commercial Officer at Arcutis Biotherapeutics, where he built and led a team of over 130 people and was responsible for the launch and brand development of ZORYVE®. Prior to that, he held sales and marketing roles of increasing responsibility at Gilead Sciences, Amgen, and Wyeth (now Pfizer). Lock holds an M.B.A. from the Cornell Johnson Graduate School of Management and a dual B.S. and B.A. in Biochemistry/Cell Biology and Psychology from the University of California, San Diego.
お知らせ • Jun 07Sionna Therapeutics, Inc. Announces Presentation of Preclinical Data That Demonstrate Proprietary Dual Combination Therapies Enable Full CFTR Correction in CFHBE ModelSionna Therapeutics, Inc. announced the presentation of preclinical data that demonstrate that the company's nucleotide-binding domain 1 (NBD1) stabilizers, in dual combinations with proprietary complementary modulators, enable full CFTR correction in CF models. The data are featured in an oral presentation and poster session at the European Cystic Fibrosis Society (ECFS) 48thEuropean Cystic Fibrosis Conference being held in Milan, Italy. Preclinical data suggest these compounds, when used in combination, have the potential to dramatically improve clinical outcomes and quality of life for people with CF." Sionna has completed Phase 1 clinical trials evaluating two potent first-in-class small molecule NBD1 stabilizers, SION-719 and SION-451. The company is also developing modulators with mechanisms of action that are complementary to NBD1, including SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. In the CFHBE model, SION-719 & SION-451 dual combinations also show potential for clinically meaningful improvement including to wild-type levels at concentrations below Emax. Earlier this week, Sionna announced its plans to advance SION-719 andSION-451 to the next stage of clinical development. The company plans to evaluate SION-719 in a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to standard of care (SOC), and SION-451 in a Phase 1 healthy volunteer trial evaluating SION-451 in two dual combinations with SION-2222 and with SION-109. Both trials are expected to initiate in the second half of 2025, with data anticipated in mid-2026.
お知らせ • Jun 04Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic FibrosisSionna Therapeutics, Inc. announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers. Sionna plans to advance both NBD1 stabilizers to the next stage of clinical development -- SION-719 to a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to SOC, and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719, and SION-451 in healthy volunteers. SionNA is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add- on to SOC and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. Positive Phase 1 Results for SION-719 and SION-451: The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719 and SION-451 in healthy volunteers. The effect of food on the PK and the bioequivalence of a tablet formulation was also evaluated in Part C of each trial. 100 subjects were dosed in the SION-719 trial and 110 subjects were dosed in the SION-451 trial. Both compounds were generally well tolerated in the Phase 1 trials. There were no serious adverse events, treatment emergent adverse events (TEAEs) that led to discontinuation of drug, or dose-limiting TEAEs observed. Most TEAEs were mild to moderate (Grade 1 or Grade 2). There was one Grade 1 TEAE related to liver function tests (LFTs) in a SION-451 treated subject who tested positive for influenza; no TEAEs related to LFTs were observed in the other cohorts of SION-451. There were no TEAEs related to LFTs in SION-719 treated subjects. The data from Part C of each trial support the use of a tablet formulation in future studies and indicate that both compounds can be dosed in a fed or fasted state. SION-719 and SION-451 each achieved desired target PK concentrations at multiple dose levels in a twice daily regimen. Both stabilizers met exposure thresholds that, based on Sionna’s preclinical CFHBE model, have the potential to provide clinically meaningful benefit if administered as an add-on to SOC or in a proprietary dual combination with complementary modulators. Next Phase of Clinical Development for NBD1 Stabilizers: SION-719 to Advance to Phase 2a Proof-of-concept in CF Patients as an Add-on to Standard of Care: Sionna is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add-on to SOC in CF patients. The trial objectives will be to show an improvement in CFTR function as defined by sweat chloride reduction and to demonstrate that NBD1 is mechanistically unique from, and synergistic with, the components of SOC. Sionna is on track to initiate this trial in the second half of 2025 with topline data anticipated in mid-2026. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SION-719, and the first subject has been dosed in a midazolam drug-drug interaction (DDI) study to confirm SION-719 can be dosed in combination with the SOC according to its label. This study will be completed prior to initiation of the Phase 2a trial. SION-451 to Advance to Phase 1 Healthy Volunteer Dual Combination Trial with Complementary Modulators: Sionna plans to initiate a Phase 1 healthy volunteer dual combination trial evaluating SION-451 in combination with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. The trial will assess the safety, tolerability, and PK of varying doses of the dual combinations, and will inform selection of a dual combination for a Phase 2b trial in CF patients. Sionna is on track to initiate the healthy volunteer trial in the second half of 2025 with topline data expected in mid-2026.
お知らせ • May 22Sionna Therapeutics to Present Preclinical Data During Oral Session At the 48Th European Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced that preclinical data assessing combinations of Sionna's nucleotide-binding domain 1 (NBD1) stabilizers, SION-451 and SION-719, with complementary Sionna CFTR modulators, galicaftor (SION-2222) and SION-109, will be featured in an oral presentation at the European Cystic Fibrosis Society's (ECFS) 48thEuropean Cystic Fibrosis Conference, being held June 4-7, 2025 in Milan, Italy.
お知らせ • Apr 30Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025.
お知らせ • Feb 07Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million.Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,588,233 Price\Range: $18 Transaction Features: Sponsor Backed Offering