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Sarepta, Elevidys

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Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
By Bhanvi Satija and Siddhi Mahatole (Reuters) -Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for its muscular gene therapy soothes immediate concerns about liquidity and the therapy's withdrawal from the market.

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Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
MSN · 23h
US FDA recommends removal of hold on Sarepta's Elevidys in some patients
FDA allows Sarepta to resume some Elevidys shipments
The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week af...

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Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys
Parents call on FDA for path forward after Duchenne's gene therapy pause | Morning in America
Sarepta's FDA woes raise questions for future of gene therapy treatments
While Sarepta’s challenges could push some away from investing in gene therapies, it could also lead to interest in different approaches.

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FDA recommends lifting voluntary hold on Elevidys in ambulatory patients
STAT · 23h
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
MIT Technology Review4d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Roche Says CHMP Issued a Negative Opinion on the Conditional Marketing Authorisation for Elevidys

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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.
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