Morningstar

Tenaya Therapeutics Says FDA Hold Lifted on Heart Disease Trial

Provided by Dow Jones Dec 11, 2025, 10:07:00 PM

By Katherine Hamilton

Tenaya Therapeutics said the Food and Drug Administration's clinical hold on its trial of TN-201, which is being developed to treat heart disease, was lifted.

The San Francisco biotechnology company said Thursday that all concerns raised by the FDA have been addressed.

Tenaya is implementing amendments to the study protocol and then plans to resume dosing. The protocol changes standardize practices in the trial.

TN-201 is being tested as a treatment of the heart condition hypertrophic cardiomyopathy.

Separately, Tenaya also said it plans to offer and sell units of stocks and warrants in a proposed public offering. Shares of the company fell 17% to $1.13 in after-hours trading.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

December 11, 2025 17:07 ET (22:07 GMT)

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