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Stoke Therapeutics (STOK) FDA Events

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FDA Events for Stoke Therapeutics (STOK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Stoke Therapeutics (STOK). Over the past two years, Stoke Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as STK-001, STK-002, and zorevunersen. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Stoke Therapeutics' Drugs in FDA Review

STK-001 - FDA Regulatory Timeline and Events

STK-001 is a drug developed by Stoke Therapeutics for the following indication: Children and Adolescents with Dravet Syndrome. 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.

STK-002 - FDA Regulatory Timeline and Events

STK-002 is a drug developed by Stoke Therapeutics for the following indication: Autosomal Dominant Optic Atrophy (ADOA). 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.

zorevunersen - FDA Regulatory Timeline and Events

zorevunersen is a drug developed by Stoke Therapeutics for the following indication: For the treatment of Dravet syndrome with a confirmed mutation. 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.

Stoke Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Stoke Therapeutics (STOK) has reported FDA regulatory activity for the following drugs: zorevunersen, STK-001 and STK-002.

The most recent FDA-related event for Stoke Therapeutics occurred on July 10, 2025, involving zorevunersen. The update was categorized as "Presentation," with the company reporting: "Stoke Therapeutics, Inc and Biogen Inc announced the presentation of data from an analysis that informed the design of the Phase 3 EMPEROR study and evaluated the potential effects of the Phase 3 zorevunersen dosing regimen."

Current therapies from Stoke Therapeutics in review with the FDA target conditions such as:

  • For the treatment of Dravet syndrome with a confirmed mutation, - zorevunersen
  • Children and Adolescents with Dravet Syndrome - STK-001
  • Autosomal Dominant Optic Atrophy (ADOA) - STK-002

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:STOK) was last updated on 7/10/2025 by MarketBeat.com Staff
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