Sarepta halts three studies testing gene therapy for muscle disorder
Sarepta Therapeutics said on Friday it had temporarily halted three trials testing its gene therapy Elevidys, following the death of a patient last month upon receiving the treatment. The company ...
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SRPT Stock Down After EMA Places Clinical Hold on DMD Gene Therapy
Shares of Sarepta Therapeutics SRPT dropped more than 6% yesterday after the EMA placed a clinical hold on all studies ...
Sarepta Therapeutics Provides Update on ELEVIDYS
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following ...
Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved ...
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Sarepta’s Duchenne Gene Therapy Placed on Hold in Europe Pending Death Investigation
The European Medicines Agency asked for three clinical trials to be placed on hold until the exact cause of death of a US ...
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Patient Dies Following Treatment With DMD Gene Therapy Elevidys
Sarepta Therapeutics announced that a patient with Duchenne muscular dystrophy who received Elevidys (delandistrogene moxeparvovec-rokl) died following treatment.
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Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.
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EMA halts Sarepta’s DMD gene therapy trial after patient death
The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' ...
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Multiple studies of Sarepta's DMD therapy halted after death
The EMA has called a temporary halt to a phase 2 trial of Sarepta's Roche-partnered Duchenne muscular dystrophy (DMD) gene ...
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A recent gene therapy death shines a light on AAV safety
The patient died from acute liver failure months after starting Elevidys, the only FDA-approved gene therapy for DMD. Its maker, Sarepta Therapeutics, hasn’t ruled out the possibility that the ...
EMA put clinical hold on Roche, Sarepta DMD studies after death
Roche (RHHBY) sent a letter dated March 31 to the World Duchenne Organization stating the European Medicines Agency requested a temporary ...
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After patient death, Sarepta and Roche pause 3 trials of gene therapy Elevidys in Europe
In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...