FDA grants RMAT designation to Tenaya's TN-401 heart gene therapy

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Go back to FDA grants RMAT designation to Tenaya's TN-401 heart gene therapy

Tenaya Therapeutics Granted U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

September 14, 2026 8:30 AM EDT

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)... More