Sarepta EU Regulatory Challenges

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Sarepta Therapeutics, Elevidys and FDA

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) gene therapy for Duchenne muscular dystrophy.

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FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy

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FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys

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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 ...

InvestorsHub on MSN3d

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 ...

3don MSN

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 ...

BioSpace3d

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 ...

Sarepta Shares Fall After Gene Therapy Hits Another Regulatory Roadblock

Separately, Sareptea said last week that it would pause the development of most of its experimental gene therapies for a different type of muscular dystrophy. The stoppage came after one of the ...

Devdiscourse2d

Health Sector Headlines: Shifts in Profits, Drug Developments, and Data-Sharing Innovations

HCA Healthcare raises 2025 profit forecast amidst insurance uncertainty while Centene anticipates a 2026 profitability boost ...

Sarepta's FDA woes raise questions for future of gene therapy treatments

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

Business Insider3mon

Sarepta announces EU regulators temporarily halted dosing of ELEVIDYS

Sarepta announces EU regulators temporarily halted dosing of ELEVIDYS TipRanks Apr. 4, 2025, 07:10 AM ...

Investing2mon

Sarepta Therapeutics’ SWOT analysis: gene therapy leader faces growth ...

This could potentially limit Sarepta’s ability to diversify its revenue streams and increase its reliance on the success of ELEVIDYS and its gene therapy pipeline. If future gene therapy programs ...

STAT5y

The FDA and Sarepta: a window into the real world of drug regulation

I t is hard to discern the true state of drug regulation from the outside, but two recent decisions by the Food and Drug Administration — to approve one drug but reject another — offer a rare ...

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