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Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...
STAT1h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
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 ...
Sarepta Therapeutics Stock Plunges After Another Patient Death Is Linked to One of Its Gene Therapies
One of biotech’s highest fliers, Sarepta Therapeutics, lost more than a third of its market value on Friday after executives said that one of its experimental gene-replacement therapies was linked to ...
'Fast Money' traders on how to play Sarepta after report FDA asked it to stop gene therapy shipments
The 'Fast Money' traders recap the recent news moving Sarepta lower and how to play the stock from here. Venezuelans deported by Trump to brutal El Salvador prison are transferred to Caracas in ...
Devdiscourse3h
FDA Scrutiny Intensifies as Sarepta Gene Therapy Faces Dire Setbacks
The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...
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STAT4hOpinion
We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...
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 ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
F.D.A. to Ask Biotech Company to Stop Shipping Treatment Linked to Patient Deaths
Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Ele­vidys, or a similar ...
Sarepta shares fall 37% as FDA questions future of key gene therapy
Sarepta Therapeutics shares plunge over 37% as FDA weighs halting shipments of its key gene therapy, Elevidys, after patient ...
Fierce Pharma5h
FDA mulls Elevidys market withdrawal following 3rd death after Sarepta gene therapy
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...