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.
