Tenaya Therapeutics Advances Cardiovascular AAV Gene Therapies TN-201 & TN-401 After Positive DSMB Reviews

Jul 30 , 2025

SOUTH SAN FRANCISCO, Calif. – July 30, 2025 – Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company, announced positive endorsements from independent Data Safety and Monitoring Boards (DSMBs) for its two cardiovascular AAV gene therapy clinical trials, MyPEAK-1 (TN-201) and RIDGE-1 (TN-401). Both DSMBs recommended proceeding per protocol, confirming favorable safety and tolerability.

“Safety is paramount, and this milestone reinforces the favorable tolerability profile emerging for both TN-201 and TN-401,” stated Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. The company anticipates sharing clinical data later this year.

MyPEAK-1 (TN-201 for MYBPC3-associated HCM): This AAV9-based gene therapy addresses hypertrophic cardiomyopathy. Following its second positive DSMB review, Tenaya will enroll expansion cohorts. Earlier data from Cohort 1 showed TN-201 reached heart cells, increased protein levels, and helped all three severe patients achieve NYHA Class I (resolution of heart failure symptoms), with reduced cardiac injury biomarkers. Longer-term Cohort 1 and initial Cohort 2 data are expected in Q4 2025.

RIDGE-1 (TN-401 for PKP2-associated ARVC): This investigational AAV9-based gene therapy targets arrhythmogenic right ventricular cardiomyopathy. After its DSMB review, Tenaya received endorsement for dose escalation and expansion of Cohort 1. The first patient in the higher dose Cohort 2 has been dosed. Initial Cohort 1 data is anticipated in Q4 2025.

These positive DSMB reviews mark significant progress for Tenaya in transforming the treatment landscape for severe genetic heart diseases.

Source:

https://investors.tenayatherapeutics.com/news-releases/news-release-details/tenaya-receives-positive-safety-reviews-independent-dsmbs

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