Sarepta Shares Rally on Plans to Seek Accelerated Nod for Duchenne Therapy

By Colin Kellaher

Shares of Sarepta Therapeutics Inc. rose sharply in early trading Friday after the genetic-medicine company said it will seek accelerated U.S. Food and Drug Administration approval of its SRP-9001 gene therapy in Duchenne muscular dystrophy.

The Cambridge, Mass., company said that it plans to file its application in the fall for SRP-9001 to treat ambulant individuals with the muscle-wasting genetic disease, and that it expect the FDA's review to run through the first half of next year.

Sarepta is racing Pfizer Inc. to develop a gene therapy for Duchenne, a rare and fatal disease that occurs in one in every 3,500 to 5,000 males.

The company, which is developing SRP-9001 with Swiss pharmaceutical company Roche Holding AG, earlier this month said the gene therapy showed significant functional improvements across several studies and time points.

Sarepta is responsible for global development and manufacturing for SRP-9001 and plans to commercialize the drug in the U.S. upon FDA approval, while Roche has exclusive commercial rights outside the U.S.

The FDA has granted several key designations to SRP-9001, including fast-track designation, which is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Sarepta shares were recently changing hands at $92.04, up 7.1%.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

July 29, 2022 10:03 ET (14:03 GMT)

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