Volatile trading in Epizyme after FDA lifts trial hold

The US Food and Drug Administration has said that the partial clinical trial hold it imposed on East Coast-USA based Epizyme (Nasdaq: EPZM) in August will be lifted.

Enrollment of new patients into a Phase II program testing the firm’s lead candidate, tazemetostat, was blocked in the second quarter of 2018 in the USA, France and Germany, after a child in a pediatric study developed a secondary T-cell lymphoblastic lymphoma.

The firm says it is now reopening enrollment in the USA, including in the affected Phase II non-Hodgkin lymphoma trial and that it will “engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries.”