Elevidys EU Rejection - Search News

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Sarepta Therapeutics, Elevidys and European Medicines Agency

InvestorsHub on MSN · 4d

Sarepta shares drop after EU regulators reject Elevidys gene therapy

Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Elevidys,

Bloomberg on MSN · 4d

Sarepta Shares Fall After EU Regulator Rejects Gene Therapy

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment in the US.

Precision Medicine Online · 4d

EMA's CHMP Recommends Against Approval for Sarepta, Roche Duchenne Gene Therapy Elevidys

Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.

Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

Investing.com South Africa4d

Sarepta stock falls after Elevidys fails to get backing by EU regulators

The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...

Fierce Pharma4d

Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

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