Sarepta Elevidys EU Setback

News

Sarepta Therapeutics, European Medicines Agency

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as the company faces intense regulatory scrutiny after two recent patient deaths tied to the treatment.

InvestorsHub on MSN · 2d

Sarepta shares drop after EU regulators reject Elevidys gene therapy

Investing.com South Africa · 2d

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

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 ...

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 ...

Medscape1mon

DMD Gene Therapy Elevidys Halted After Second Patient Death - Medscape

Sarepta Therapeutics has temporarily suspended use of the gene therapy Elevidys in non-ambulatory patients with Duchenne muscular dystrophy (DMD) after a second patient taking the drug died from ...

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