05:21 AM EDT, 06/21/2024 (MT Newswires) -- (Updates with the stock move in the headline and the first paragraph.)

Sarepta Therapeutics ( SRPT ) shares were up almost 34% in premarket activity on Friday after the company said overnight the US Food and Drug Administration approved the expansion of Elevidys to include patients ages 4 and above with Duchenne muscular dystrophy and a confirmed mutation in the DMD gene.

"Confirming the functional benefits, the FDA granted traditional approval for ambulatory patients," the company said late Thursday. Continued approval for non-ambulatory patients may be contingent upon verification of clinical benefit in a confirmatory trial, Sarepta.

Envision study SRP-9001-303, a placebo-controlled phase 3 trial of Elevidys in non-ambulatory and older ambulatory individuals with Duchenne, is underway and intended to serve as a postmarketing requirement for the expanded label, the company said.

In line with a collaboration agreement signed with Sarepta in 2019, Roche Holding ( RHHVF ) is responsible for regulatory approvals and bringing Elevidys to patients outside the US.

Price: 164.99, Change: +41.49, Percent Change: +33.60