NasdaqGS:SRPTBiotechs
How Investors Are Reacting To Sarepta Therapeutics (SRPT) Pushing Duchenne Drugs Toward Full FDA Approval
Earlier this week, Sarepta Therapeutics said it plans to file supplemental new drug applications by the end of April to convert the accelerated approvals of its Duchenne muscular dystrophy exon-skipping drugs AMONDYS 45 and VYONDYS 53 to traditional approvals, using Phase 3 ESSENCE data and real-world evidence that the FDA has agreed to review.
The move to seek full approvals for AMONDYS 45 and VYONDYS 53 could be important for the durability of Sarepta’s Duchenne franchise alongside its...