Tenaya Therapeutics(TNYA) Newsfilter·2025-01-13 14:16Core Insights - Tenaya Therapeutics is advancing its gene therapy programs, TN-201 and TN-401, targeting cardiomyopathies, with significant milestones expected in 2025 [1][2][3] Program Updates - TN-201: A gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) is currently in the MyPEAK-1 Phase 1b/2 clinical trial. Additional data from Cohort 1 is anticipated in the first half of 2025, including safety assessments and biopsy results from the first three patients dosed [3][6] - TN-401: A gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) is in the RIDGE-1 Phase 1b clinical trial. Initial clinical data from the first cohort is expected in the second half of 2025 [3][7] Clinical Trial Details - The MyPEAK-1 trial for TN-201 has shown promising initial results, with the first two patients demonstrating detectable vector DNA and transgene RNA expression. The trial is expanding to include adults with obstructive forms of HCM [3][4] - The RIDGE-1 trial for TN-401 has enrolled over 100 participants, with initial seroprevalence data indicating low antibody levels to AAV9, which is crucial for eligibility [10] Strategic Priorities - Tenaya plans to enhance its capabilities in drug discovery and genetic medicine delivery, focusing on both rare genetic disorders and prevalent heart conditions in 2025 [5][8] - The company aims to complete enrollment for both Cohort 1 of RIDGE-1 and Cohort 2 of MyPEAK-1 in the first half of 2025, with data presentations planned for the second half of the year [3][10] Market Context - MYBPC3 mutations are the most common genetic cause of HCM, affecting approximately 120,000 patients in the U.S. alone, while PKP2 mutations are linked to over 70,000 ARVC cases [6][7] - Both TN-201 and TN-401 have received Fast Track and Orphan Drug Designations from the FDA, indicating their potential significance in treating these conditions [6][7]