Tenaya Therapeutics falls after FDA clinical hold on heart disorder trial

[Heart, stethoscope and EKG]
MarsBars/E+ via Getty Images

Tenaya Therapeutics (TNYA [https://seekingalpha.com/symbol/TNYA]) stock fell after its mid-stage trial for TN-201, aimed at treating MYBPC3-associated hypertrophic cardiomyopathy, was put on clinical hold due to a request from the FDA.

The stock is down 16% after the bell.

The FDA has asked for changes to the trial protocol to ensure consistent patient monitoring and management of the immunosuppression regimen across all trial locations.

This request for protocol modification came after discussions with the FDA regarding the future of the TN-201 program and is based on data reviewed by the trial's independent Data Safety Monitoring Board in the summer of 2025.

Despite this hold, Tenaya does not anticipate [https://seekingalpha.com/filing/33517440]any impact on the data milestones or development timelines for TN-201.

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