FDA accepts Sarepta's SRP-9001 BLA for priority review

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA), submitted by rare diseases specialist Sarepta Therapeutics (Nasdaq: SRPT), seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD).

SRP-9001 has been granted Priority Review by the FDA, with a regulatory action date of May 29, 2023. SRP-9001 is an investigational gene therapy for Duchenne being developed in partnership with Swiss pharm giant Roche (ROG: SIX), which will commercialize the drug outside the USA.

Sarepta’s shares were up more than 9% at $120.24 in early trading this morning following the announcement.