FDA Grants Regenerative Medicine Advanced Therapy Designation To Tenaya Therapeutics’ TN-401, Gene Therapy Candidate For Treatment Of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy
Benzinga Newsdesk 1 month ago
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RMAT Designation Supported by Positive Interim Data from RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 which Demonstrated Reduced Arrhythmia Burden Additional Data and Updates on Regulatory Discussions Anticipated in 4Q
RMAT Designation Supported by Positive Interim Data from RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 which Demonstrated Reduced Arrhythmia Burden
Additional Data and Updates on Regulatory Discussions Anticipated in 4Q 2026
SOUTH SAN FRANCISCO, Calif., Sept. 14, 2026 (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 that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TN-401, Tenaya’s gene therapy candidate for the treatment of PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC).