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FDA asks Sarepta to stop shipping gene therapy

BioPharma Dive · 2d

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.

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· 1d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

· 2d · on MSN

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

2don 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.

2don MSN

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

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Fierce Biotech2d

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.

2don MSN

Sarepta Shares Crash on Report That 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 ...

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