FDA Places Clinical Hold on Tenaya Therapeutics' TN-201 Trial

Reuters11-08

FDA Places Clinical Hold on Tenaya <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' TN-201 Trial

Tenaya Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 1b/2a MyPEAK-1 trial evaluating TN-201 for MYBPC3-associated hypertrophic cardiomyopathy. The FDA requested a protocol amendment to standardize patient monitoring and immunosuppression management across trial sites. Tenaya stated that the request followed proactive discussions with the agency and was based on previously reviewed safety data, which indicated TN-201 was generally well tolerated. The company is working with the FDA to resolve the hold and does not expect it to impact the program's 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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-272423), on November 07, 2025, and is solely responsible for the information contained therein.

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Tenaya Therapeutics Inc. published th","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"TNYA":"Tenaya Therapeutics Inc","BK4539":"次新股","BK4139":"生物科技"},"translate_title":"FDA暂停Tenaya Therapeutics的TN-201试验临床","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TNYA":0.9},"content_text":"FDA Places Clinical Hold on Tenaya Therapeutics' TN-201 Trial\n    \n\nTenaya Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 1b/2a MyPEAK-1 trial evaluating TN-201 for MYBPC3-associated hypertrophic cardiomyopathy. The FDA requested a protocol amendment to standardize patient monitoring and immunosuppression management across trial sites. Tenaya stated that the request followed proactive discussions with the agency and was based on previously reviewed safety data, which indicated TN-201 was generally well tolerated. 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