Commercial Fate Of Sarepta’s DMD Gene Therapy Remains Tied To EMBARK
The company guided investors to expect a narrow initial label under a US FDA accelerated approval for SRP-9001, with expansion possible based on EMBARK.
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Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says
Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.
Slim Adcomm Majority Boosts Sarepta’s Gene Therapy In Duchenne Muscular Dystrophy
Accelerated approval seems imminent after a majority of the US FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted the risk-benefit balance supported it.
Roche Pharma CEO Graham On Growth Prospects, Policy Pressures, Alzheimer’s And More
“I don’t think anybody can afford to not be in the Alzheimer’s race,” Graham said in one of her first public appearances since becoming CEO of Roche pharmaceuticals.