Sarepta Elevidys EU Setback

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Europe, gene therapy and Sarepta

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,

Reuters on MSN · 2d

EU regulator does not recommend approval of Sarepta's muscle disorder gene therapy

Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare muscular dystrophy, the health agency said on Friday. Shares of the company were down nearly 17% at $10.

Fierce Pharma · 2d

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 to finding a path forward for the one-time Duchenne muscular dystrophy (D | Friday,

GlobalData on MSN2d

CHMP rejects Elevidys in latest setback for Sarepta

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

BioSpace2d

Sarepta Fallout Continues With EU’s Negative Opinion of Elevidys in Ambulatory Patients

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

4don MSN

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular ...

Fierce Pharma4d

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

Benzinga.com1mon

Did The FDA Make A Mistake? Sarepta's Elevidys Approval ... - Benzinga

FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target Tim Melvin’s system has spotted 10X ...

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