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Coya Therapeutics Faces FDA Review Delay for ALS Treatment Trial

Strategic Insights

— 1 min read

Coya Therapeutics, a biopharmaceutical company, has disclosed that the U.S. Food and Drug Administration (FDA) is unable to meet its initial review goal date for the Investigational New Drug (IND) Application for its planned clinical study, entitled "Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Open Label Extension (OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)". The FDA has informed Coya that they will provide their decision on approval of the IND as soon as possible, and expect that it will be provided no later than August 29, 2025.

Key Takeaways:

  • Coya Therapeutics has submitted additional non-clinical data to support the initiation of its IND Application for the Phase 2 study on June 30, 2025.
  • The FDA has informed Coya that due to its present workload and lack of resources, it is unable to meet its initial review goal date for the IND of July 30, 2025.
  • The FDA expects to provide a decision on the approval of the IND no later than August 29, 2025.
  • The Phase 2 study aims to evaluate the safety and efficacy of COYA 302, a treatment for Amyotrophic Lateral Sclerosis (ALS), in a randomized, double-blind, placebo-controlled, multi-center, 24-week study with an additional 24-week open-label extension.
  • Coya Therapeutics has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Statistics:

  • July 30, 2025: FDA's Initial Review Goal Date for the IND
  • August 29, 2025: Expected Date for FDA's Decision on Approval of the IND
  • 24 weeks: Duration of the Phase 2 study
  • 24 weeks: Duration of the open-label extension of the Phase 2 study
  • 2025: Year in which Coya Therapeutics submitted additional non-clinical data to support the IND Application

Sources:

  • UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 29, 2025

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