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 Monday.
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 Hold on Epizyme's Tazemetostat")...
BCIQ Target Profiles