Sarepta Shares Surge After FDA Recommends Lifting Hold On Elevidys Gene Therapy For Ambulatory Use

Sarepta Therapeutics

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(RTTNews) - Shares of Sarepta Therapeutics (SRPT) surged approximately 47% in after-hours trading on NasdaqGS after the U.S. Food and Drug Administration recommended lifting the voluntary hold on the company's gene therapy, Elevidys, for ambulatory patients with Duchenne Muscular Dystrophy (DMD). Following an investigation into the recent death of an 8-year-old patient, the FDA concluded that the incident was not related to the gene therapy product itself.

The FDA said it will continue to work with the sponsor regarding non ambulatory patients, which remains subject to a voluntary hold, following two deaths.

In a separate press release, Sarepta announced that it will resume shipping ELEVIDYS to sites of care for treatment of ambulatory patients with Duchenne imminently.

Elevidys is an adeno-associated virus vector-based gene therapy using Sarepta Therapeutics' AAVrh74 Platform Technology for the treatment of Duchenne muscular dystrophy. The product is administered as a single intravenous dose. Duchenne muscular dystrophy is a rare genetic condition characterized by progressive muscular weakness. The disease occurs due to a defective gene.

SRPT closed Monday's regular trading at $13.86 up $1.93 or 16.18%. In the after-hours trading the stock further gained $6.50 or 46.90%.

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