FDA Events for Sionna Therapeutics (SION)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Sionna Therapeutics (SION).
Over the past two years, Sionna Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SION-719. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SION-719 - FDA Regulatory Timeline and Events
SION-719 is a drug developed by Sionna Therapeutics for the following indication: cystic fibrosis transmembrane conductance regulator (CFTR) protein.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SION-719
- Announced Date:
- June 4, 2025
- Indication:
- cystic fibrosis transmembrane conductance regulator (CFTR) protein
Announcement
Sionna Therapeutics, 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.
AI Summary
Sionna Therapeutics announced positive Phase 1 data for its first-in-class NBD1 stabilizers, SION-719 and SION-451, in healthy volunteers. The trials showed that both compounds were generally well tolerated and successfully reached the desired pharmacokinetic targets established in preclinical models. These encouraging results support the potential of the stabilizers to improve CFTR function in cystic fibrosis patients, either as an add-on to the standard of care or in combination with complementary modulators.
Based on these findings, Sionna plans to advance SION-719 into a Phase 2a proof-of-concept trial in cystic fibrosis patients and to initiate a Phase 1 dual combination trial with SION-451 in healthy volunteers. The positive outcomes have reinforced the company’s commitment to developing innovative treatments that address unmet needs in cystic fibrosis care.
Read Announcement- Drug:
- SION-719
- Announced Date:
- May 22, 2025
- Indication:
- cystic fibrosis transmembrane conductance regulator (CFTR) protein
Announcement
Sionna 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) 48th European Cystic Fibrosis Conference, being held June 4-7, 2025 in Milan, Italy.
AI Summary
Sionna Therapeutics has announced it will present new preclinical data at the European Cystic Fibrosis Society’s 48th Conference in Milan, Italy, from June 4‑7, 2025. The study examines how combining their NBD1 stabilizers, SION‑451 and SION‑719, with complementary CFTR modulators, galicaftor (SION‑2222) and SION‑109, can work together to fully correct the defective ΔF508‑CFTR protein found in cystic fibrosis.
Scheduled for an oral presentation on June 6, 2025, the findings aim to show that this synergistic approach may restore normal CFTR function. The research offers valuable insights into developing more effective treatments, potentially improving patient outcomes and quality of life for those living with cystic fibrosis.
Read Announcement
Sionna Therapeutics FDA Events - Frequently Asked Questions
As of now, Sionna Therapeutics (SION) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sionna Therapeutics (SION) has reported FDA regulatory activity for SION-719.
The most recent FDA-related event for Sionna Therapeutics occurred on June 4, 2025, involving SION-719. The update was categorized as "Positive Data," with the company reporting: "Sionna Therapeutics, 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."
Currently, Sionna Therapeutics has one therapy (SION-719) targeting the following condition: cystic fibrosis transmembrane conductance regulator (CFTR) protein.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SION) was last updated on 7/11/2025 by MarketBeat.com Staff
