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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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

The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reut...

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FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

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

The FDA's request follows the death of two teenage boys who received Elevidys, a gene therapy approved in the United States to treat a muscle-wasting condition called Duchenne muscular dystrophy.

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

STAT · 3h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

Fierce Biotech12h

UPDATED: Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death

On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.

BioPharma Dive1h

Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.

4hon MSN

Gene-therapy company to eliminate 21 Durham employees as part of major restructuring

Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.

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Friday's movers: Sarepta, Norfolk Southern, Netflix and more

These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg reported,

Investor's Business Daily on MSN8h

The FDA Will Reportedly Ask Sarepta To Stop Selling Elevidys. Shares Plummet.

Sarepta stock crashed Friday on reports the FDA will ask the biotech company to stop shipments of its approved gene therapy, Elevidys.

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