Commercial Fate Of Sarepta’s DMD Gene Therapy Remains Tied To EMBARK
Executive Summary
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.
You may also be interested in...
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.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.