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Biotech / Medical : Immunomedics (IMMU) - moderated
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From: luckydog887/25/2025 6:53:35 AM
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REUTERS

Jul-25-2025 6:42 a.m. ET

July 25 (Reuters) - Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' (SRPT) gene therapy Elevidys for a type of rare muscular dystrophy, the health agency said on Friday.

MT NEWSWIRES

Jul-25-2025 6:53 a.m. ET

06:53 AM EDT, 07/25/2025 (MT Newswires) -- Sarepta Therapeutics (SRPT) shares fell 15% in premarket trading on Friday after its gene therapy drug Elevidys was temporarily suspended by the Brazilian Health Regulatory Agency (Anvisa) late Thursday.

The suspension is in effect until safety uncertainties related to reports of fatal cases of acute liver failure in patients treated with the product in the United States are fully clarified, the regulator said.

The decision was made in light of new regulatory information released by the US Food and Drug Administration, which reported three deaths associated with the use of gene therapy products with AAVrh74 vector technology developed by Sarepta, the statement added.
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