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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental trea...

· 21h · on MSN

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

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Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPh...

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Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

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Sarepta shares slump after third patient death this year

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Sarepta shares slump on reports of third patient death this year

On Wednesday, Sarepta announced a restructuring plan that included 500 job cuts and halting development of several gene therapies for limb-girdle muscular dystrophy.

STAT · 22h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

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Sarepta plunges after third patient death tied to gene therapy - report

Hoodline8h

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

1don MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.

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Sarepta Therapeutics Provides Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

1don MSN

Sarepta Shares Crash on Report FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.

Sarepta Therapeutics Stock Tumbles on Report of Third Death in Clinical Trial

Shares of Sarepta Therapeutics plummeted nearly 30% premarket Friday following a report that a third patient has died during a clinical trial for one of its medications.

Sarepta: Safety And Efficacy Flaws Undermine Gains On Restructuring News

Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.