Epizyme's NDA Accepted, And Other News: The Good, Bad And Ugly Of Biopharma [Seeking Alpha]
Epizyme, Inc. (EPZM)
Last epizyme, inc. earnings: 2/24 06:30 am
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epizyme.com
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Source: Seeking Alpha
Summary An NDA submitted by Epizyme for tazemetostat has been accepted. Sellas finalizes phase 3 plans. Navidea undergoes dilution. The FDA Accepts Epizyme Marketing Application Epizyme ( EPZM th Tazverik was approved As it is largely expected that the FDA will decide in favor of the company, Epizyme is looking forward to having two FDA approvals within six months of each other. The company’s sNDA submission is supported by updated Phase 2 efficacy and safety data. The results had shown Epizyme is also carrying out a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK with Revlimid® plus Rituxan® in FL patients going through second line or later treatment. It is expected that nearly 500 patients will be enrolled in the study. These patients will be put into different cohorts on the basis of their E2H2 mutation status. Epizyme is currently carrying out the safety Run In portion of the trial. It is expected that the trial will move into the efficacy portio
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