FDA Grants Regenerative Medicine Advanced Therapy Designation To Tenaya Therapeutics’ TN-401, Gene Therapy Candidate For Treatment Of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy
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
Tenaya's heart gene therapy got fast track approval from the FDA. This means the treatment showed promise in early tests, so the company can move faster toward helping patients.
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