FDA Lifts Clinical Hold on Tenaya Therapeutics’ MyPEAK-1 Trial

Reuters12-12

FDA Lifts Clinical Hold on Tenaya <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' MyPEAK-1 Trial

Tenaya Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its MyPEAK-1™ Phase 1b/2a clinical trial of TN-201, a gene therapy being developed for the treatment of MYBPC3-associated hypertrophic cardiomyopathy. The decision follows Tenaya's successful resolution of all FDA concerns related to the hold. The company is now implementing protocol amendments agreed upon with the FDA and plans to resume dosing in collaboration with clinical sites. No new safety issues have been identified, and Tenaya does not expect the hold to affect its data milestones or development timelines.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tenaya Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9600996-en) on December 11, 2025, and is solely responsible for the information contained therein.

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