- The FDA has approved AMONDYS 45 (casimersen) from Sarepta Therapeutics (NASDAQ:SRPT) for the treatment of Duchenne Muscular Dystrophy in patients that have a mutation amendable to exon 45 skipping.
- Commercial distribution will begin immediately.
- Sarepta will continue the placebo-controlled ESSENCE confirmatory trial that is expected to conclude in 2024.
- AMONDYS 45 is the third RNA exon-skipping treatment from Sarepta for Duchenne Muscular Dystrophy to win FDA approval, following EXONDYS 51 (eteplirsen) in 2016 and VYONDYS 53 (golodirsen) in 2019.
- Sarepta shares are up 5.2% to 88.69 in afternoon trading.
Sarepta shares up as FDA approves AMONDYS 45 for Duchenne Muscular Dystrophy
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