Epizyme discards a failed program for tazemetostat as execs work to get an FDA hold lifted -- shares crater
Epizyme’s woes with its lead program for tazemetostat just got much worse.
The FDA stepped in and slapped a partial hold on their $EPZM lead drug — halting enrollment in clinical trials — close to three months ago after a pediatric patient developed a secondary T-cell lymphoblastic lymphoma. Today in its Q2 report Epizyme added that it is shutting down a top-ranked development program for diffuse large B-cell lymphoma, DLBCL, after concluding that it wouldn’t succeed.
Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone.
Two other combination studies for DLBCL are continuing.
The bad news was held back in their release until Epizyme CEO Robert Bazemore was able to tally the upbeat things happening at the biotech. Researchers say they’ve been working with the FDA on the hold, and expect they are within close range of getting it lifted.
It didn’t help. Epizyme shares ended the day down 24%.
Epizyme is also lining up an application for tazemetostat for epithelioid sarcoma, but has had to delay it until H1 2019 because of the hold. And that won’t please their investors, either.