(RTTNews) - Sarepta Therapeutics, Inc. (SRPT), Friday acknowledged the Committee for Medicinal Products for Human Use's negative opinion on the conditional marketing authorization for ELEVIDYS in ambulatory individuals ages three to seven years for the treatment of Duchenne muscular dystrophy.
Meanwhile, its partner Roche will continue its dialogue with the European Medicines Agency to explore a potential path forward to make ELEVIDYS available in the region.
Further, the company stated that ELEVIDYS showed clinically meaningful and statistically significant improvements across important secondary endpoints of functional outcome measures in EMBARK study. However, it did not meet the primary endpoint of the study.
In the pre-market hours, SRPT is moving down 10.64 percent, to $11.50 on the Nasdaq.
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