Sarepta Announces FDA Acceptance Of SNDAs For AMONDYS 45 And VYONDYS 53

India, June 30 -- Sarepta Therapeutics, Inc. (SRPT) announced that the U.S. FDA has accepted for review the supplemental New Drug Applications (sNDAs) for AMONDYS 45 and VYONDYS 53, therapies for Duchenne muscular dystrophy.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.

Duchenne muscular dystrophy (DMD) is a rare genetic disorder that causes progressive muscle weakness and loss of function. AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) are exon-skipping therapies designed to address specific mutations within the DMD gene. The sNDAs seek to convert their current accelerated approvals into traditional approvals, supported by data from the ESSENCE confirmatory study, published real-wo...