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Sarepta Will Resume Gene Therapy Shipments After FDA Review of Recent Patient Death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...
FDA Says Sarepta Can Resume Gene Therapy in Some Patients
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
Fierce Pharma1 天
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...
BioSpace5 天
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
GEN - Genetic Engineering and Biotechnology News4 天
Sarepta to Resume Shipping DMD Gene Therapy to Ambulant Patients
Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...
TipRanks on MSN3 天
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
Chemistry World3 天
Sarepta gene therapy deaths highlight tragic rare disease dilemma
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Fierce Pharma5 天
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Rheumatology Advisor5 天
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.
FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.