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Epizyme on go with tazemetostat NDA in Q4

|About: Epizyme, Inc. (EPZM)|By:, SA News Editor

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.

Pipeline update:

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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