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Epizyme (EPZM) aims at developing its lead pipeline candidate, tazemetostat, which is under FDA review with an action date of Jan 23, 2020.
Epizyme (EPZM) reports wider-than-expected loss in the second quarter of 2019 and the FDA accepts the NDA for its lead pipeline candidate, tazemetostat.
Epizyme (EPZM) delivered earnings and revenue surprises of 0.00% and 424.45%, respectively, for the quarter ended June 2019. Do the numbers hold clues to what lies ahead for the stock?
Epizyme, Inc. , a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that Robert Bazemore, president and chief executive officer, will present at the Wedbush PacGrow 2019 Healthcare Conference on Tuesday, Aug.
Epizyme (EPZM) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Epizyme has proposed an indication of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 23, 2020.
Mr. Tombesi brings over 30 years of extensive financial and accounting expertise to Epizyme, most recently serving as the chief financial officer at Insmed, Incorporated. “Paolo is a seasoned healthcare and financial executive with a distinguished track record of leading financial operations and strategy, overseeing capital allocation and fund raising.
The data show that tazemetostat demonstrated meaningful clinical activity and was generally well tolerated in both patients with EZH2 activating mutations and those with wild-type EZH2. The data will be presented today in an oral presentation entitled “Interim update from a Phase 2 multicenter study of tazemetostat, an EZH2 inhibitor, in patients with relapsed or refractory follicular lymphoma” at the International Conference on Malignant Lymphoma (ICML) by Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire de Lille, France, an investigator in the Phase 2 trial.
For biotech stocks, the week was back loaded with multiple conferences scheduled for the later half of the week. Nevertheless, there were volatile moves in some low-float, thinly traded stocks. Looking ...
Epizyme, Inc. (EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that management will host a conference call on Friday, June 21, 2019 at 8:30 a.m. ET to discuss updated data from an ongoing Phase 2 study of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma. The data, which will be from a recent June 2019 data cutoff date, will be reported in an oral presentation by Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire and study investigator, at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
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The data will be presented today in an oral presentation entitled “Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients with epithelioid sarcoma” at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting by Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Tumori, Milan, and an investigator in the Phase 2 clinical trial. In July 2017, Epizyme completed enrollment of 62 patients in the epithelioid sarcoma cohort of its Phase 2 trial.
Epizyme (EPZM) submits an NDA filing for tazemetostat to the FDA with an objective to treat patients suffering metastatic epithelioid sarcoma, not eligible for curative surgery. Shares inch up.
Cambridge-based Epizyme is now awaiting FDA for approval for its epigenetics first product, tazemetostat, with plans to quickly expand its applications.
Epizyme, Inc. (EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. Tazemetostat is an oral, first-in-class, EZH2 inhibitor discovered by Epizyme and being developed for a range of cancers and treatment settings.