07:35 AM EDT, 06/25/2025 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) gene therapy, Elevidys, is being investigated by the US Food and Drug Administration following reports of two deaths after receiving the treatment, multiple media outlets reported Tuesday, citing the FDA.

The investigation comes amid safety concerns after the company reported the second death earlier this month of a non-ambulatory Duchenne muscular dystrophy patient within 90 days of treatment with Elevidys.

The two patients suffered from acute liver failure and were hospitalized within two months of receiving treatment with Elevidys, the health regulator reportedly said, adding that it is looking into further regulatory action.

The US prescribing information for Elevidys, which was approved by the FDA in 2024, warns of acute liver injury but does not mention liver failure or death, according to Reuters.

Sarepta did not immediately respond to MT Newswires' request for comment on the matter.