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Sarepta, Elevidys and FDA

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' (SRPT.O) muscular disorder gene therapy Elevidys.

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Sarepta soars after FDA says some patients can get Elevidys

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US FDA recommends removal of hold on Sarepta's Elevidys in some patients

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Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics (SRPT.O) said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular disorder who can walk, after the FDA recommended the removal of a vo...

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Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments

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FDA allows Sarepta to resume some Elevidys shipments

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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

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Parents call on FDA for path forward after Duchenne's gene therapy pause | Morning in America

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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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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.

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Roche pauses shipments of Elevidys gene therapy outside US

Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics .

Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday that shipments of Elevidys, or delandistrogene moxeparvovec, will resume to sites of care imminently for ambulatory patients with Duchenne.

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Sarepta Therapeutics

Food and Drug Administration