Sarepta Moves Closer To FDA Approval For Duchenne Muscular Dystrophy Drugs - Sarepta Therapeutics (NASDAQ

FDA accepts Sarepta's filings seeking traditional approval for AMONDYS 45 and VYONDYS 53, with a decision expected by February 2027.

martedì 30 giugno 2026 New tab

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The U.S.

Food and Drug Administration (FDA) accepted on Tuesday Sarepta Therapeutics Inc.'s (NASDAQ:SRPT) supplemental New Drug Applications seeking to convert the accelerated approvals of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) into traditional approvals for Duchenne muscular dystrophy (DMD). • Sarepta Therapeutics shares are climbing with conviction.

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The FDA approved VYONDYS 53 in 2019 and AMONDYS 45 in 2021.

The agency set a Prescription Drug User Fee Act target action date of Feb. 28, 2027.