EMA put clinical hold on Roche, Sarepta DMD studies after death

Roche (RHHBY) sent a letter dated March 31 to the World Duchenne Organization stating the European Medicines Agency requested a temporary clinical hold on three studies involving Sarepta’s (SRPT) Duchenne muscular dystrophy gene therapy Elevidys after a 16-year-old boy who received the treatment died. “We are pausing enrollment and dosing of participants in these studies at EU country study sites, as well as the UK for the Roche-sponsored ENVOL study. Patient safety monitoring for already enrolled participants and ongoing collection of data will continue,” Roche added. Shares of Sarepta are down 9% to $56.86 in premarket trading.

Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

Disclaimer & DisclosureReport an Issue