Sarepta Shares Rally on Plans to Seek Accelerated Nod for Duchenne Therapy
30 July 2022 - 12:18AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 29, 2022 10:03 ET (14:03 GMT)
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