ELEVIDYS – Talk Bio

Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

6 hours ago talkbio0Tagged concerns, ELEVIDYS, gene therapy, halt, Muscular Dystrophy, Duchenne, patient deaths, Roche (company), Safety, shipment, United States Food and Drug Administration

Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths

Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure

9 hours ago talkbio0Tagged concerns, DMD, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Safety, shipment, Suspensions, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

11 hours ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

11 hours ago talkbio0Tagged drug rejection, ELEVIDYS, gene therapy, George Tidmarsh, Liver Failure, Acute, pharmaceutical manufacturing, reshoring, Study on Hold, United States Food and Drug Administration

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing

Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys

1 day ago talkbio0Tagged ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Pauses, Safety, shipment, United States Food and Drug Administration

Sarepta Therapeutics; FDA; Elevidys; Duchenne muscular dystrophy; gene therapy; shipment pause; patient deaths; safety concerns

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

2 days ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

2 days ago talkbio0Tagged ELEVIDYS, gene therapy, Liver Failure, Market, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Authority, United States Food and Drug Administration, Withdraw (activity)

FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

2 days ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

5 days ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning

6 days ago talkbio0Tagged acute liver injury, black box, Cautionary Warning, ELEVIDYS, gene therapy, layoffs, Muscular Dystrophy, Duchenne, pipeline shift, restructuring, RNA, Small Interfering

Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring