Epizyme (EPZM) Trading of Stock Halted; Oncology Drug Advisory Committee to Review Tazemetostat at 8:00 a.m. ET Today
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 18, 2019--
Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, announced today that trading of its common stock has been halted. The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting at 8:00 a.m. ET today to discuss Epizyme’s New Drug Application (NDA) for tazemetostat, an oral, first-in-class EZH2 inhibitor, for the treatment of patients with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for curative surgery.
Epizyme’s NDA submission is based primarily on data from the 62 patient ES cohort of its ongoing Phase 2 study of tazemetostat. The ODAC is scheduled to start at 8:00 a.m. ET. The briefing materials can be found on FDA’s website here. Tazemetostat was submitted under the Accelerated Approval pathway and is under Priority Review with FDA, with an assigned Prescription Drug User Fee Act (PDUFA) date of Jan. 23, 2020.
Today’s advisory committee vote will be non-binding, but FDA takes its recommendations into consideration when reviewing related applications for marketing approval.
About Epizyme, Inc.
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, an oral, first-in-class EZH2 inhibitor, with investigational studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also exploring additional molecules in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme’s science seeks to match targeted medicines with the patients who need them. For more information, visit www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the FDA will approve the NDA submitted for tazemetostat; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; whether Fast Track Designation and Orphan Drug Designations will provide the benefits for which tazemetostat is eligible; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company’s cash resources will be sufficient to fund the company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the company’s therapeutic candidates; and other factors discussed in the “Risk Factors” section of the company’s most recent Form 10-Q filed with the SEC and in the company’s other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
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Erin Graves, (617) 500-0615
Alicia Davis, (910) 620-3302
THRUST Strategic Communications
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: Epizyme, Inc.
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PUB: 12/18/2019 07:05 AM/DISC: 12/18/2019 07:05 AM