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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.”
