August 6, 2025 — Leads & Copy — Tenaya Therapeutics, Inc. (NASDAQ: TNYA) has completed enrollment in cohorts 1 and 2 of its MyPEAK™-1 Phase 1b/2 trial of TN-201 for MYBPC3-associated HCM. A positive DSMB safety review has enabled enrollment of expansion cohorts.
Cohort 1 of the RIDGE™-1 Phase 1b Trial of TN-401 has been enrolled, and the first PKP2-associated ARVC patient has been dosed in Cohort 2 following a DSMB recommendation to dose escalate and expand. Data readouts from both the TN-201 and TN-401 clinical programs are planned for the fourth quarter of 2025, and the company’s cash runway extends into the second half of 2026.
According to Faraz Ali, Chief Executive Officer of Tenaya, target enrollment was achieved in the ongoing gene therapy clinical trials of TN-201 for MYBPC3-associated HCM and of TN-401 for PKP2-associated ARVC during the first half of 2025. Ali added that the subsequent positive recommendations for dose escalation and/or expansion from each trial’s independent Data Safety Monitoring Board following a review of all available safety data for TN-201 and TN-401 are critical milestones in the mission to address two of the most common and deadly genetic cardiomyopathies.
In May, Tenaya completed enrollment and dosing of three patients at the 6E13 vg/kg dose level (Cohort 2) in the MyPEAK™-1 Phase 1b/2 clinical trial of TN-201 for MYBPC3-associated HCM. The independent Data Safety Monitoring Board (DSMB) for the MyPEAK-1 trial determined that TN-201 had an acceptable safety profile to enroll dose expansion cohorts at either the 3E13 vg/kg or 6E13 vg/kg dose level. Tenaya currently anticipates enrolling patients in the 6E13 vg/kg dose expansion cohort.
Enrollment of the first cohort of three patients receiving TN-401 at a dose level of 3E13 vg/kg in the RIDGE-1 Phase 1b clinical trial was completed in April 2025.
In July 2025, the RIDGE-1 DSMB reviewed all available data from Cohort 1 and issued a positive recommendation regarding both enrollment of a higher dose cohort at 6E13 vg/kg and enrollment of additional patients at the 3E13 vg/kg dose.
Tenaya is enrolling Cohort 2 and the first patient has been dosed at the 6E13 vg/kg dose level. Tenaya may enroll additional patients at the 3E13 vg/kg dose.
As of June 30, 2025, cash, cash equivalents and investments in marketable securities were $71.7 million. The company expects that its current funds are sufficient to support planned company operations into the second half of 2026.
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com
Source: Tenaya Therapeutics, Inc.
