© Reuters. Sarepta (SRPT) tumbles 15% as FDA wants extra time to finish a evaluate of SRP-9001
Sarepta Therapeutics (NASDAQ:) shares fell as a lot as 14.8% in early Wednesday buying and selling after the medical analysis firm stated the U.S. Meals and Drug Administration (FDA) knowledgeable the corporate it “requires modest extra time to finish the evaluate” of SRP-9001.
Therefore, the PDUFA date for ‘9001 shall be delayed till June 22, 2023, from Might twenty ninth.
The remedy is at the moment beneath evaluate for the therapy of ambulant people with Duchenne muscular dystrophy (DMD).
The corporate stated the FDA additionally indicated that it intends to probably grant an accelerated approval for SRP-9001, initially to be used in Duchenne sufferers ages 4-5 years previous, as soon as the evaluate is accomplished.
RBC analysts stated the delay “gives concrete timelines.”
“Though preliminary potential label limitation is a slight disappointment, we see restricted impact on ‘9001’s medium/long-term alternative and stay believers into EMBARK and on ‘9001’s long-term prospects. As such, we imagine weak point presents a shopping for alternative.”
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