Sarepta Elevidys EU Setback

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EU, Sarepta and Elevidys

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.

Investing.com South Africa · 2d

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

Fierce Pharma · 2d

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

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 ...

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 ...

Nasdaq1mon

From $172 to $20: Sarepta's Spectacular Fall - Nasdaq

Sarepta Therapeutics (NASDAQ: SRPT) shares plunged 42% on Monday, June 16, following reports of a second patient death associated with its Duchenne muscular dystrophy gene therapy, Elevidys. In ...

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 ...

Boston Herald1mon

Second death reported with gene therapy for muscular dystrophy

Elevidys is the first gene therapy approved in the U.S. for the rare muscle-wasting condition, but it has faced scrutiny since its accelerated approval in 2023. Related Articles Today in History ...

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