Sarepta Therapeutics Updates On Regulatory Review Of SRP-9001; New Regulatory Action Date Is June 22, 2023
Portfolio Pulse from Benzinga Newsdesk
Sarepta Therapeutics has updated the regulatory review of SRP-9001, with a new action date of June 22, 2023. The FDA is considering granting accelerated approval for SRP-9001 for Duchenne patients aged 4-5 years old, subject to the completion of the BLA review.
May 24, 2023 | 12:05 pm
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Sarepta Therapeutics' SRP-9001 may receive accelerated approval from the FDA for Duchenne patients aged 4-5 years old, subject to the completion of the BLA review. The new regulatory action date is June 22, 2023.
The FDA's consideration of accelerated approval for SRP-9001 is a positive development for Sarepta Therapeutics. If granted, it could lead to faster market access and increased revenue for the company. The new regulatory action date provides a clear timeline for investors to anticipate potential approval, which could positively impact the stock price in the short term.
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