Tenaya Therapeutics (TNYA) on Nov. 8, 2025: FDA Places Clinical Hold on TN‑201 Trial as AHA 2025 Showcases Encouraging MyPEAK‑1 Data
What happened today (Nov. 8) Tenaya Therapeutics (NASDAQ: TNYA) presented new interim results from its MyPEAK‑1 Phase 1b/2a trial evaluating TN‑201, an AAV9 gene‑replacement therapy designed to deliver a working MYBPC3 gene to cardiomyocytes for MYBPC3‑associated hypertrophic cardiomyopathy (HCM). The late‑breaking presentation in New Orleans highlighted longer‑term follow‑up for the first‑dose cohort (3E13 vg/kg) and initial readouts at the higher dose (6E13 vg/kg), with a simultaneous publication in Cardiovascular Research. GlobeNewswire Cleveland Clinic, which led the podium talk, summarized the early experience: six adults treated across two dose cohorts were monitored for months to >1 year; the therapy reached heart