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Sionna Therapeutics (SION) FDA Events

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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.

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

  • 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 7/10/2025 by MarketBeat.com Staff
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