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FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death
Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was linked to the deaths of two teenage boys earlier this year.
Sarepta Axes 500, 36% of Workforce, in Restructuring after DMD Patient Deaths
Sarepta Therapeutics said it will eliminate 36% of its workforce—approximately 500 jobs—in a restructuring that follows the deaths of two Duchenne muscular dystrophy (DMD) patients following treatment with the marketed gene therapy Elevidys® (delandistrogene moxeparvovec-rokl).
Most investors don’t see the drugmaker’s executive management as credible, following the failure to disclose a patient death, ...
The downturn began just days after Sarepta's second quarter earnings ... including for SRP-9004, as part of a restructuring. But none of the executives on the call mentioned the death.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm ...
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
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