Epizyme Announces Positive Pre-NDA Meeting for Tazemetostat for Follicular Lymphoma, Pipeline Updates and Third Quarter 2019 Results
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct 30, 2019--
Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced recent tazemetostat program updates, including successfully completing a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for its tazemetostat program for follicular lymphoma (FL), G9a program updates and third quarter 2019 financial results.
“We are very pleased with the outcome of our recent pre-NDA meeting and the continued alignment with FDA on our registration strategy for FL patients, regardless of their EZH2 status, who have received at least two prior systemic therapies,” said Dr. Shefali Agarwal, chief medical officer of Epizyme. “FL remains an incurable disease, and we believe strongly in the potential of tazemetostat to make a difference for these patients. We are on track to submit our FL NDA for accelerated approval in December and look forward to continuing to engage with FDA as we work to bring tazemetostat to both FL and epithelioid sarcoma patients in the U.S. next year.”
Tazemetostat Program Updates
G9a Program Update
Leadership Team Expansion
“Over the course of 2019, we’ve made significant progress building out critical functions, advancing and expanding tazemetostat development, and continuing our evolution toward becoming a commercial company,” said Robert Bazemore, president and chief executive officer of Epizyme. “I am proud of what we have achieved thus far, with much more to come in the next several months. We have multiple trials to initiate, a second NDA to submit and a first U.S. commercial launch to execute, if approved. We are thrilled to be on the cusp of delivering tazemetostat to patients and look forward to continued progress.”
Third Quarter 2019 Financial Results
Based on its current operating plan, Epizyme continues to expect its cash runway to extend into the first quarter of 2021.
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 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.
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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: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; 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; 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: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL ONCOLOGY
SOURCE: Epizyme, Inc.
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PUB: 10/30/2019 06:30 AM/DISC: 10/30/2019 06:30 AM