News

GlobalData on MSN7d
CHMP rejects Elevidys in latest setback for Sarepta
Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...
BioWorld6d
CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...
InvestorsHub on MSN7d
Sarepta shares drop after EU regulators reject Elevidys gene therapy
Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European ...
Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy
Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular dystrophy patients.
Fierce Pharma7d
Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
EMA issues negative opinion on Sarepta-Roche’s DMD gene therapy
Friday said that the European Medicines Agency has issued a negative opinion on the conditional marketing authorization for Elevidys, intended for ambulatory patients aged three to seven with Duchenne ...