05:41 PM EDT, 06/20/2024 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) said late Thursday 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. Continued approval for non-ambulatory patients may be contingent upon verification of clinical benefit in a confirmatory trial, Sarepta said.

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.

Sarepta shares surged 37% in recent after-hours trading.

Price: 169.67, Change: +45.17, Percent Change: +37.78