Tenaya wins FDA RMAT designation for TN-401 in PKP2-associated ARVC
TNYA•FDA grants RMAT designation for TN-401
The FDA granted RMAT designation to Tenaya Therapeutics’ TN-401 gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy.
The designation followed interim RIDGE-1 Phase 1b/2 data showing reduced premature ventricular contractions and fewer non-sustained ventricular tachycardias.
The company expects additional trial data and regulatory discussion updates in 4Q 2026 as it prepares for a pivotal study.
