Sarepta Therapeutics Inc. (SRPT) announced U.S. Food and Drug Administration approval of an expansion to the labeled indication for Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy or DMD with a confirmed mutation in the DMD gene who are at least 4 years of age.
SRPT closed Thursday's regular trading at $123.50 up $5.98 or 5.09%. In the after-hours trading the stock further gained $41.49 or 33.60%.
The FDA granted traditional approval for patients aged four years and above who can walk, and accelerated approval for those unable to walk.
Continued approval for non-ambulatory Duchenne patients may be contingent upon verification of clinical benefit in a confirmatory trial. Elevidys is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
As part of a collaboration agreement signed in 2019, Sarepta is working with Roche to transform the future for the Duchenne community, enabling those living with the disease to maintain and protect their muscle function.
Sarepta is responsible for regulatory approval and commercialization of Elevidys in the U.S., as well as manufacturing. Roche is responsible for regulatory approvals and bringing Elevidys to patients across the rest of the world.
Elevidys is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy - mutations or changes in the DMD gene that result in the lack of dystrophin protein - through the delivery of a transgene that codes for the targeted production of Elevidys micro-dystrophin in skeletal muscle.
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