Tenaya Receives Positive Safety Reviews from Independent DSMBs to Advance Both TN-201 and TN-401 Gene Therapy Clinical Trials as Designed

Enrollment in Both Dose Cohorts of the MyPEAK™-1 Phase 1b/2 Clinical Trial of TN-201 for Hypertrophic Cardiomyopathy (HCM) Complete; Follow-up Data from Cohort 1 and Initial Data from Cohort 2 Expected in Fourth Quarter of 2025

First Patient Dosed in 6E13 vg/kg Cohort 2 of RIDGE™-1 Phase 1b Clinical Trial of TN-401 for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Initial Cohort 1 Data for TN-401 and Enrollment of Additional Patients in Both Dose Cohorts Planned for Fourth Quarter of 2025

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., July 30, 2025 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced positive endorsements from each trial’s independent Data Safety and Monitoring Board (DSMB) to proceed per protocol with its two cardiovascular gene therapy clinical trials, MyPEAK-1 for TN-201 and RIDGE-1 for TN-401.

“Safety is paramount, and this milestone reinforces the favorable tolerability profile emerging for both TN-201 and TN-401 and highlights the appropriateness of our immunosuppressant regimen to manage patients. We are very encouraged by the DSMBs’ endorsements to proceed per protocol into expansion cohorts at either dose level for TN-201, and to expand at the current dose and escalate to the higher dose level for TN-401, with our first Cohort 2 patient already dosed,” said Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. “We look forward to sharing clinical data from both programs later this year as we continue to advance our mission to transform the treatment landscape for patients with serious cardiovascular diseases.”

MyPEAK-1 DSMB Review
This is the second positive DSMB review for the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy, a condition caused by insufficient levels of myosin-binding protein C (MyBP-C).

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