SION (Sionna Therapeutics, Inc.) PDUFA Date | FDA Catalyst & Approval Status

May 27, 2026

Sionna Therapeutics to Participate in Upcoming June 2026 Investor Conferences

Sionna Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in two upcoming investor conferences in June 2026. The events include a presentation at the Jefferies Global Healthcare Conference and a fireside chat at the Goldman Sachs Global Healthcare Conference. Sionna aims to revolutionize cystic fibrosis treatment through novel therapies targeting the CFTR protein.

May 13, 2026

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Sionna Therapeutics to Participate in the 2026 RBC Capital Markets Global Healthcare Conference

Sionna Therapeutics will participate in the 2026 RBC Capital Markets Global Healthcare Conference on May 20, 2026. The event will include a fireside chat with management, highlighting the company's efforts to transform cystic fibrosis treatment. Sionna aims to develop novel therapies that enhance CFTR protein function, focusing on the F508del mutation.

May 12, 2026

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Sionna Therapeutics Reports First Quarter 2026 Financial Results

Sionna Therapeutics has reported its first-quarter financial results for 2026, highlighting the completion of enrollment in the Phase 2a trial for SION-719, which is evaluating cystic fibrosis treatment. The company maintains a strong cash position of approximately $289.9 million, expected to sustain operations through 2028. However, Sionna recorded a net loss of $26.8 million, an increase from the previous year, alongside rising research and development expenses. Topline data from ongoing trials is anticipated for summer 2026.

Apr 27, 2026

Sionna Therapeutics Completes Enrollment in PreciSION CF Phase 2a Trial Evaluating NBD1 Stabilizer, SION-719, Added to Standard of Care in Participants with Cystic Fibrosis

Sionna Therapeutics has completed enrollment in its PreciSION CF Phase 2a trial, evaluating SION-719, an NBD1 stabilizer, alongside the standard care Trikafta in cystic fibrosis patients. This trial aims to assess the safety and pharmacokinetics of SION-719 and its impact on CFTR function. Data from the trial is expected in summer 2026.

Apr 7, 2026

Sionna Therapeutics to Participate in the Raymond James 2026 Biotech Innovation Symposium

Sionna Therapeutics, a clinical-stage biopharmaceutical company, will participate in one-on-one investor meetings at the Raymond James 2026 Biotech Innovation Symposium on April 14, 2026. The company focuses on developing novel therapies aimed at normalizing CFTR protein function to improve treatment outcomes for cystic fibrosis patients. Sionna's innovative approach includes small molecules targeting the F508del mutation and complementary CFTR modulators.

Sionna Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results

Sionna Therapeutics reported its financial results for Q4 and full year 2025, highlighting ongoing clinical trials for its NBD1 stabilizers SION-719 and SION-451. The company maintains a robust cash position of approximately $310.3 million, expected to support operations until 2028. Topline data from ongoing trials is anticipated in mid-2026, marking significant progress in their pipeline for cystic fibrosis treatments.

Feb 23, 2026

Sionna Therapeutics to Participate in Upcoming March 2026 Investor Conferences

Sionna Therapeutics, a clinical-stage biopharmaceutical company, will participate in upcoming investor conferences. The company focuses on developing novel therapies for cystic fibrosis by targeting the CFTR protein. Their approach aims to improve the quality of life for patients by correcting genetic defects. Live webcasts of the presentations will be available on their website.

Feb 4, 2026

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Sionna Therapeutics to Present at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026

Sionna Therapeutics will present at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on February 11, 2026. The company aims to revolutionize cystic fibrosis treatment by developing novel medicines that normalize CFTR protein function. Their approach focuses on correcting defects caused by the F508del genetic mutation and improving patient quality of life.

Jan 5, 2026

Sionna Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference

Sionna Therapeutics will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026. The company focuses on developing novel medicines to enhance the function of the CFTR protein for cystic fibrosis treatment. A live webcast of the presentation will be available on their Investor Relations website.

Nov 24, 2025

Sionna Therapeutics to Participate in Upcoming December Investor Conferences

Sionna Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in upcoming investor conferences. The company aims to revolutionize cystic fibrosis treatment by developing novel medicines that stabilize the CFTR protein. Live webcasts of the presentations will be available on their Investor Relations website, ensuring accessibility for stakeholders.

Nov 5, 2025

Sionna Therapeutics Reports Third Quarter 2025 Financial Results

Sionna Therapeutics reported its Q3 2025 financial results, highlighting the initiation of the PreciSION CF Phase 2a trial for SION-719 and a Phase 1 trial for SION-451. The company has a solid cash reserve of $325 million, expected to sustain operations until 2028. Despite a net loss of $20.3 million, the company remains optimistic about its pipeline and community engagement.

Nov 4, 2025

Sionna Therapeutics to Participate in Upcoming November Investor Conferences

Sionna Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in upcoming investor conferences. The company aims to revolutionize cystic fibrosis treatment by developing novel medicines targeting the CFTR protein. Live webcasts of the presentations will be available on their Investor Relations website, allowing for broader access to their developments.

Oct 24, 2025

Sionna Therapeutics Announces Presentation of SION-719 and SION-451 Phase 1 Data and Poster of New Preclinical Data on the Impact of NBD1 Stabilizers on F508del-CFTR Half-Life at the 2025 North American Cystic Fibrosis Conference

Sionna Therapeutics presented promising Phase 1 data for its NBD1 stabilizers, SION-719 and SION-451, at the 2025 North American Cystic Fibrosis Conference. The data indicated that both compounds were well tolerated and met pharmacokinetic targets. Additionally, new preclinical findings demonstrated that these stabilizers could restore the half-life of F508del-CFTR to levels comparable to wild-type CFTR. The company is advancing its clinical programs with expectations for further results in mid-2026.

Oct 21, 2025

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Sionna Therapeutics Announces Initiation of PreciSION CF Phase 2a Trial Evaluating NBD1 Stabilizer, SION-719, When Added to Standard of Care in Participants with Cystic Fibrosis

Sionna Therapeutics has initiated the PreciSION CF Phase 2a trial to evaluate SION-719, a novel NBD1 stabilizer, in cystic fibrosis patients. This trial aims to assess the safety and efficacy of SION-719 when added to the current standard of care, Trikafta. Topline results are anticipated by mid-2026, potentially marking a significant advancement in CF treatment.

Oct 1, 2025

Sionna Therapeutics to Present Data at the 2025 North American Cystic Fibrosis Conference

Sionna Therapeutics will present data at the 2025 North American Cystic Fibrosis Conference in Seattle. The presentations will focus on the safety and pharmacokinetics of their novel NBD1 stabilizers, SION-719 and SION-451, from phase 1 studies. The conference will take place from October 22-25, 2025, showcasing advancements in cystic fibrosis treatment.

Sionna Therapeutics Appoints Caroline Stark Beer as Chief Business Officer

Sionna Therapeutics has appointed Caroline Stark Beer as its new Chief Business Officer. With over 20 years of experience in the life sciences, Beer is expected to enhance the company's corporate development efforts. Sionna focuses on developing innovative therapies for cystic fibrosis, aiming to improve patient outcomes significantly.

Aug 27, 2025

Sionna Therapeutics to Participate in Upcoming September Investor Conferences

Sionna Therapeutics, a clinical-stage biopharmaceutical company focused on cystic fibrosis treatments, has announced its participation in two upcoming investor conferences in September 2025. Management will engage in fireside chats at the Cantor Global Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference in New York. The company aims to revolutionize CF treatment through innovative medicines targeting the CFTR protein. Live webcasts will be available for investors, emphasizing Sionna's commitment to transparency and communication.

Aug 25, 2025

Sionna 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 Fibrosis

Sionna Therapeutics has initiated a Phase 1 trial for SION-451, a novel NBD1 stabilizer, in combination with other CFTR modulators. The trial aims to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. Topline data is expected in mid-2026, which will inform a subsequent Phase 2b trial for cystic fibrosis patients.

Sionna Therapeutics Reports Second Quarter 2025 Financial Results

Sionna Therapeutics reported its financial results for Q2 2025, highlighting positive Phase 1 data for its investigational drugs SION-719 and SION-451. Both compounds, first-in-class NBD1 stabilizers, exceeded pharmacokinetic targets and were well tolerated. The company plans to initiate a Phase 2a proof-of-concept trial for SION-719 later in 2025, with topline data expected in mid-2026. Moreover, Sionna maintains a robust cash position that is projected to ensure operational funding through 2028.

Sionna Therapeutics Announces Presentation of Preclinical Data that Demonstrate Proprietary Dual Combination Therapies Enable Full CFTR Correction in CFHBE Model

Sionna Therapeutics announced promising preclinical data demonstrating that their proprietary dual combination therapies can achieve full CFTR correction in cystic fibrosis models. This data was presented at the 48th European Cystic Fibrosis Conference. The company is advancing its lead compounds, SION-719 and SION-451, into clinical trials, aiming to improve treatment outcomes for cystic fibrosis patients.

Jun 4, 2025

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Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic Fibrosis SION-719 and SION-451 were generally well tolerated an

Sionna Therapeutics reported positive Phase 1 clinical trial results for its NBD1 stabilizers, SION-719 and SION-451, demonstrating favorable safety and pharmacokinetic profiles. The company plans to advance SION-719 into a Phase 2a trial for cystic fibrosis patients and SION-451 into a Phase 1 healthy volunteer trial by the second half of 2025. These advancements aim to enhance treatment efficacy for cystic fibrosis, which continues to have significant unmet needs. The successful outcomes of these trials mark important milestones for Sionna as it seeks to transform cystic fibrosis management.

Jun 3, 2025

Sionna Therapeutics to Present at the Goldman Sachs 46th Annual Global Healthcare Conference

Sionna Therapeutics, a clinical-stage biopharmaceutical company focused on cystic fibrosis treatment, announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. The event will occur in Miami, Florida, on June 11, 2025. Sionna aims to develop innovative therapies that normalize CFTR protein function, potentially leading to improved outcomes for patients. The live webcast of the presentation will be available on their investor relations website, along with a replay afterwards.

May 22, 2025

Sionna Therapeutics to Present Preclinical Data During Oral Session at the 48th European Cystic Fibrosis Conference

Sionna Therapeutics announced its participation in the 48th European Cystic Fibrosis Conference, where it will present preclinical data on its CFTR modulators. This data includes novel combinations of Sionna's NBD1 stabilizers and complementary therapies aimed at improving treatment outcomes for cystic fibrosis. The oral presentation will take place on June 6, 2025, and is part of ongoing efforts to innovate CF treatments. Sionna aims to address the underlying genetic defects in cystic fibrosis through its research.

May 12, 2025

Sionna Therapeutics Reports First Quarter 2025 Financial Results

Sionna Therapeutics reported its financial results for Q1 2025, highlighting the completion of Phase 1 dosing for its drug candidates SION-719 and SION-451, which are expected to produce topline data this quarter. The company has a strong financial position with $354.7 million in cash, expected to sustain its operations through 2028. Management is focused on initiating a Phase 2a proof-of-concept trial and at least one dual combination MAD trial in late 2025, with significant data anticipated in mid-2026. However, the net loss for the quarter increased versus the previous year, raising concerns over R&D expenditures.

Apr 30, 2025

Sionna Therapeutics to Present at The Citizens Life Sciences Conference 2025

Sionna Therapeutics, a clinical-stage biopharmaceutical company, will present at The Citizens Life Sciences Conference on May 7, 2025. The company's focus is on developing novel medications to treat cystic fibrosis by normalizing the function of the CFTR protein. Sionna aims to improve clinical outcomes and quality of life for patients with CF through innovative approaches, including small molecules correcting specific genetic mutations. The live webcast will be available on its Investor Relations website, emphasizing the company's commitment to transparency and investor engagement.

Mar 20, 2025

Sionna Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results Phase 1 MAD dosing completed for SION-451 and final MAD cohort of SION-719 planned; Interim data in healthy volunteers show potential to pro

Sionna Therapeutics has released its financial results for Q4 and the full year of 2024, reporting successful completion of Phase 1 MAD dosing for SION-451 and plans for the final cohort of SION-719. Encouraging interim data suggest these compounds may offer meaningful clinical benefits for cystic fibrosis patients, with topline results expected in early 2025. The company completed a substantial IPO, generating around $219 million to support its clinical pipeline, which extends its operational runway into 2028. They are on track to initiate further clinical trials in 2025, including a Phase 2a proof-of-concept trial and combination trials in healthy volunteers.

Feb 24, 2025

Sionna Therapeutics to Present at the 45th Annual TD Cowen Health Care Conference

Sionna Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the 45th Annual TD Cowen Health Care Conference scheduled for March 3, 2025. The presentation will highlight Sionna's innovative approach to treating cystic fibrosis by targeting the CFTR protein. The company aims to improve treatment outcomes for patients with cystic fibrosis through its development of small molecules and complementary CFTR modulators. A live webcast of the event will be available on Sionna's Investor Relations website.

Sionna Therapeutics Announces Closing of $219.2 million Upsized Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

Sionna Therapeutics, a biopharmaceutical firm focused on cystic fibrosis treatment, has completed its upsized initial public offering, raising $219.2 million. The offering included 12,176,467 shares sold at a price of $18.00 each, with all shares sold by the company. Trading of its stock began on February 7, 2025, under the ticker SION on the Nasdaq. The funds will support the development of novel therapies aimed at normalizing cystic fibrosis transmembrane conductance regulator (CFTR) protein function.