FDA asks Sarepta to stop shipping gene therapy
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Late on Friday, Sarepta refused an FDA request to voluntarily halt shipments of Elevidys—a request made after it first surfaced in news reports, the company said in a statement. “Based on our comprehensive scientific interpretation of the data ...
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
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.