21.06.2024 03:45:03 - dpa-AFX: Sarepta Therapeutics' Elevidys Approved By FDA For Duchenne Muscular Dystrophy; Stock Surges

SOUTH SAN FRANCISCO (dpa-AFX) - Sarepta Therapeutics Inc. (SRPT) announced
U.S. Food and Drug Administration approval of an expansion to the labeled
indication for Elevidys (delandistrogene moxeparvovec-rokl) to include
individuals with Duchenne muscular dystrophy or DMD with a confirmed mutation in
the DMD gene who are at least 4 years of age.

SRPT closed Thursday's regular trading at $123.50 up $5.98 or 5.09%. In the
after-hours trading the stock further gained $41.49 or 33.60%.

The FDA granted traditional approval for patients aged four years and above who
can walk, and accelerated approval for those unable to walk.

Continued approval for non-ambulatory Duchenne patients may be contingent upon
verification of clinical benefit in a confirmatory trial. Elevidys is
contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD
gene.

As part of a collaboration agreement signed in 2019, Sarepta is working with
Roche to transform the future for the Duchenne community, enabling those living
with the disease to maintain and protect their muscle function.

Sarepta is responsible for regulatory approval and commercialization of Elevidys
in the U.S., as well as manufacturing. Roche is responsible for regulatory
approvals and bringing Elevidys to patients across the rest of the world.

Elevidys is a single-dose, adeno-associated virus (AAV)-based gene transfer
therapy for intravenous infusion designed to address the underlying genetic
cause of Duchenne muscular dystrophy - mutations or changes in the DMD gene that
result in the lack of dystrophin protein - through the delivery of a transgene
that codes for the targeted production of Elevidys micro-dystrophin in skeletal
muscle.

For More Such Health News, visit rttnews.com



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
ROCHE HLDG AG GEN. 855167 Hamburg 0,000 28.06.24 08:12:05 ±0,000 ±0,00% 0,000 0,000 0,000 245,550

© 2000-2024 DZ BANK AG. Bitte beachten Sie die Nutzungsbedingungen | Impressum
2024 Infront Financial Technology GmbH