Sarepta Therapeutics (SRPT) said Tuesday the US Food and Drug Administration has accepted its supplemental new drug applications for two treatments targeting Duchenne muscular dystrophy.
The regulator established a target action date of Feb. 28, 2027, to complete its evaluation of both Amondys 45 and Vyondys 53, the company said.
The company submitted the requests to transition the medical products from accelerated to standard approvals.
Shares of the company rose more than 3% in Tuesday premarket activity.
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