By Colin Kellaher

 

Sarepta Therapeutics Inc. on Friday said it plans to file for U.S. Food and Drug Administration accelerated approval of its SRP-9001 gene therapy to treat ambulant individuals with Duchenne muscular dystrophy.

The Cambridge Mass., genetic-medicine company said it expects an FDA review to begin this year and run through the first half of 2023.

Duchenne muscular dystrophy is a rare, fatal neuromuscular genetic disease that occurs in roughly one in every 3,500 to 5,000 males.

The FDA in 2020 granted fast-track designation, which aims to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs, to SRP-9001, which has also received the agency's rare-pediatric-disease and orphan-drug designations.

Sarepta is developing SRP-9001 with Swiss pharmaceutical company Roche Holding AG under a 2019 partnership that included an upfront payment of more than $1 billion.

Trading in shares of Sarepta, which closed Thursday at $85.93, was halted premarket on Friday.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

July 29, 2022 07:34 ET (11:34 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Sarepta Therapeutics (NASDAQ:SRPT)
Historical Stock Chart
From Aug 2022 to Sep 2022 Click Here for more Sarepta Therapeutics Charts.
Sarepta Therapeutics (NASDAQ:SRPT)
Historical Stock Chart
From Sep 2021 to Sep 2022 Click Here for more Sarepta Therapeutics Charts.