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0 -0.000396904147648264 0.000198452073824273 -0.00138916451676921 -0.000992260369120801 -0.00674737051002176 -0.00694582258384603 -0.00535820599325255
Stock impact report

Roche launches new Elevidys study after feedback from European regulator [Yahoo! Finance]

ROCHE HOLDING LTD S/ADR (RHHBY) 
NASDAQ:AMEX Investor Relations: roche.com/investors.htm
Company Research Source: Yahoo! Finance
The therapy for duchenne muscular dystrophy (DMD), for which Roche partners ?with American Sarepta Therapeutics, had failed to win backing from the European Medicines Agency (EMA) last year after coming under scrutiny following two patient deaths tied to the treatment. • ?The phase III ?study aims to generate additional placebo-controlled data required for a regulatory re-submission with EMA. • Elevidys ?is currently approved in nine countries for ambulatory boys with a confirmed DMD mutation, including in the United States, ?which had ?temporarily ordered a pause ?in shipments last July. • ?DMD is a rare, inherited disease that mostly affects boys and causes muscles to weaken steadily over time. • The study will span more than 72 weeks and evaluate the efficacy and safety of Elevidys compared to placebo ?in around 100 early ambulatory boys ?with DMD. The primary endpoint ?is the change in ?the so-called "time to rise" from the floor ?velocity. • "Our confidence is rooted in Show less Read more
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