06:22 AM EDT, 06/21/2024 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) shares soared early Friday after the Food and Drug Administration granted expanded approval for Elevidys, the company's gene therapy for the deadly Duchenne muscular dystrophy, or DMD, disease.

The drug can now be used by Duchenne patients with a confirmed mutation in the DMD gene who are aged four years and above, the medical research and drug development firm said late Thursday. The FDA initially cleared the product in June last year through its accelerated approval pathway for children four through five years.

Sarepta's stock has gained 28% so far this year and jumped more than 33% in recent premarket activity.

"The initial approval of Elevidys was a significant milestone, and the expanded indication means clinicians now have a treatment option for the great majority of boys and young men living with Duchenne," Jerry Mendell, senior advisor of medical affairs at Sarepta, said in a statement. DMD is a rare and serious genetic condition which worsens over time, leading to weakness and wasting away of the body's muscles.

"Today's approval broadens the spectrum of patients with Duchenne muscular dystrophy eligible for this therapy, helping to address the ongoing, urgent treatment need for patients with this devastating and life-threatening disease," Peter Marks, director of the FDA's center for biologics evaluation and research, said in a separate statement.

The regulator granted traditional approval to Elevidys for ambulatory patients, who are able to walk around without assistance, and accelerated approval for non-ambulatory individuals, according to Sarepta. Continued approval for non-ambulatory patients may depend on verification of clinical benefit in a confirmatory trial, which is already underway, the company added.

Sarepta last month reported total revenue of $413.5 million for the first quarter, up from $253.5 million a year ago, mainly due to increasing demand for Elevidys. The product has logged cumulative sales of more than $334 million since its initial approval, Chief Executive Doug Ingram said at the time.

In 2019, Sarepta signed a licensing agreement to provide Swiss pharmaceutical company Roche exclusive commercial rights to Elevidys outside the US. Roche is also responsible for acquiring regulatory approvals for the product in the rest of the world.

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