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FDA gives the go-ahead to restart Elevidys shipments
In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the safety labelling process and risk-mitigation approach for non-ambulatory patients."
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...
Analysts’ view on the stock has dramatically changed over the past few months. Currently, only 21% of the 29 analysts ...
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...
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