FDA lifts holds on Epizyme, Sarepta programs

FDA lifted separate clinical holds on tazemetostat from Epizyme Inc. (NASDAQ:EPZM) and a gene therapy program targeting micro-dystrophin from Sarepta Therapeutics Inc. (NASDAQ:SRPT), the companies said Sept. 24.

Epizyme is reopening enrollment in all of its U.S. tazemetostat trials, in which new enrollment had been paused. FDA placed the partial hold in April following a report of a patient who developed secondary T cell lymphoma during a Phase I pediatric trial. Patients already enrolled who had not experienced disease progression were allowed to continue receiving tazemetostat (see "FDA Places Clinical Hold on PhI of Epizyme's Tazemetostat")...