Sarepta to Seek Accelerated FDA OK of SRP-9001 in Duchenne Muscular Dystrophy
July 29 2022 - 7:49AM
Dow Jones News
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.
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Apr 2023 to Apr 2024
