Epizyme (NASDAQ:EPZM) announces that, based on FDA feedback, it expects to file its U.S. marketing application for tazemetostat for EZH2 mutation-positive and wild-type relapsed/refractory follicular lymphoma (FL) in Q4. Data from the ongoing Phase 2 study will support the application.
A NDA submission for tazemetostat in epitheloid sarcoma should be filed next quarter. If approved, the company plans to commercialize in the U.S. on its own.
Combo study comparing tazemetostat to Roche's Rituxan (rituximab) and Celgene's Revlimid (lenalidomide) in relapsed/refractory FL should launch this year.
Company is exploring additional opportunities for the combination of tazemetostat and the chemo regimen R-CHOP in FL.
A combo study in castration-resistant prostate cancer should launch mid-year. Assessment in platinum-resistant cancers should start in H2.
The company and Roche's (OTCQX:RHHBY) Genentech have decided not to move forward with a study of tazemetostat and Tecentriq (atezolizumab) non-small cell lung cancer (NSCLC).
On the capital front, its current resources should be sufficient to fund operations into Q2 2020.
Management will host a conference call this morning at 8:30 am ET to discuss its corporate update.
Update: Shares are up 23% premarket on modest volume.
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