News

BioSpace2d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Sarepta Makes Big Cuts After Patient Deaths. Its Prospects Remain Uncertain.
The pharma company said it would lay off a third of its workforce and add a black-box warning to its controversial gene ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
BioSpace4d
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
Sarepta: Safety And Efficacy Flaws Undermine Gains On Restructuring News
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...
Fierce Biotech9d
UPDATED: Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
Sarepta: Despite Restructuring, Downgrading To Sell After Latest Developments
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm ...