Roche says will work with EMA on path forward for Elevidys

Roche (RHHBY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion on the conditional marketing authorization for Elevidys for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy. “Given the high unmet need in DMD, Roche plans to continue to work with the EMA to explore a potential path forward,” the company said in a statement. “We are disappointed by the CHMP’s negative opinion, given the urgent need for disease-modifying therapies for children in the EU living with Duchenne…We are confident in the value Elevidys can bring to ambulatory patients,” said Levi Garraway, Chief Medical Officer of Roche. Roche partners with Sarepta (SRPT) on Elevidys outside of the U.S. Sarepta is down 13% to $11.20 in premarket trading while Roche is down 10c to $41.34.