© Reuters. Sarepta (SRPT) tumbles 15% as FDA needs more time to complete a review of SRP-9001
Sarepta Therapeutics (NASDAQ:) shares fell as much as 14.8% in early Wednesday trading after the medical research company said the U.S. Food and Drug Administration (FDA) informed the company it “requires modest additional time to complete the review” of SRP-9001.
Hence, the PDUFA date for ‘9001 will be delayed until June 22, 2023, from May 29th.
The therapy is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD).
The company said the FDA also indicated that it intends to potentially grant an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old, once the review is completed.
RBC analysts said the delay “offers concrete timelines.”
“Although initial potential label limitation is a slight disappointment, we see limited effect on ‘9001’s medium/long-term opportunity and remain believers into EMBARK and on ‘9001’s long-term prospects. As such, we believe weakness presents a buying opportunity.”