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NASDAQ:TNYA 8 November 2025

Tenaya Therapeutics (TNYA) on Nov. 8, 2025: FDA Places Clinical Hold on TN‑201 Trial as AHA 2025 Showcases Encouraging MyPEAK‑1 Data

Tenaya Therapeutics (TNYA) on Nov. 8, 2025: FDA Places Clinical Hold on TN‑201 Trial as AHA 2025 Showcases Encouraging MyPEAK‑1 Data

The FDA placed a clinical hold on Tenaya’s MyPEAK-1 trial for TN-201, requiring protocol changes for patient monitoring and immunosuppression. Tenaya reported new interim data showing six treated patients had increased MyBP-C protein and improved cardiac biomarkers, with all six no longer symptomatic. Shares dropped over 20% after the hold was announced. The company does not expect data timelines to change.
8 November 2025
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