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About EpizymeEpizyme is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative personalized therapeutics for patients with genetically defined cancers. We systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of our product candidates is directed towards patients with a particular genetically defined cancer. Our approach is part of a broader trend towards personalized therapeutics based on first identifying the underlying cause of a disease affecting specific patient populations, applying rational drug design tools to create a therapeutic to bind with a molecular target in the identified disease pathway and using a companion diagnostic to select the right patients for treatment.
We have built a proprietary product platform that we use to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic. When Epizyme was founded, we recognized that the HMT class of enzymes might contain many potential oncogenes and, therefore, presented the opportunity to discover, develop and commercialize multiple personalized therapeutics.
We have prioritized 20 HMTs as attractive targets for personalized therapeutics based on their oncogenic potential. Our two most advanced therapeutic product programs target the HMTs DOT1L (for the treatment of mixed lineage leukemia, or MLL-r) and EZH2 (for a genetically defined subtype of non-Hodgkin lymphoma). We believe that our ongoing Phase 1 study for EPZ-5676, targeting DOT1L, is the first clinical trial of an HMT inhibitor. We expect to initiate a Phase 1/2 clinical trial of EPZ-6438 targeting EZH2 in 2Q 2013.
We were founded in 2007 and are led by a management team with extensive experience in the pharmaceutical industry. We have entered into therapeutic collaborations with Celgene, Eisai and Glaxo Group Limited (an affiliate of GlaxoSmithKline), or GSK, that have provided us with approximately $120 million in non-equity funding through March 31, 2013. As of March 31, 2012, we had $85 million in cash and cash equivalents.
301 articles about Epizyme
FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
The U.S. Food and Drug Administration granted accelerated approval to Tazverik for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
Epizyme, Inc., a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration has granted accelerated approval of TAZVERIK™ for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial.
1/20/2020January isn’t a particularly busy month for PDUFA dates for the U.S. Food and Drug Administration, with only two scheduled for the month. Here’s a look.
Epizyme Announces Exercise of $50 Million Option with Royalty Pharma and Highlights Key 2020 Initiatives to Build Long-Term Value
Epizyme, Inc. announced that it exercised its option to sell $50 million of its common stock to Royalty Pharma, pursuant to the terms of the companies’ recent funding agreements announced on November 4, 2019.
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019
Epizyme Announces FDA Advisory Committee Votes Unanimously in Favor of Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 11 - 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surger
Epizyme (EPZM) Trading of Stock Halted; Oncology Drug Advisory Committee to Review Tazemetostat at 8:00 a.m. ET Today
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that trading of its common stock has been halted.
Epizyme Presents Updated Phase 2 Data at the 2019 ASH Annual Meeting Supporting Planned Tazemetostat NDA Submission for Follicular Lymphoma
NDA Submission for Accelerated Approval of Tazemetostat for Patients with Relapsed or Refractory Follicular Lymphoma on Track for December 2019
Epizyme Establishes Agreements for Up to $270 Million in Funding to Support Tazemetostat Commercialization and Pipeline Advancement
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced funding agreements with Royalty Pharma and its affiliate Pharmakon Advisors that, in aggregate, could bring in up to $270 million in capital, significantly strengthening Epizyme’s financial position and extending its operating runway into at least 2022.
Epizyme Announces Positive Pre-NDA Meeting for Tazemetostat for Follicular Lymphoma, Pipeline Updates and Third Quarter 2019 Results
Pre-NDA Meeting Supports Registration Strategy for Tazemetostat for Follicular Lymphoma Patients with and without EZH2 Activating Mutations and Planned NDA Submission in December 2019
Epizyme, Inc. announced the appointments of experienced commercial executive, Grant Bogle, and research and development executive, Victoria Richon, Ph.D., to the company’s board of directors.
Epizyme, Inc. announced that Robert Bazemore, president and chief executive officer, will participate in the following September investor conferences
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, provided business and pipeline highlights and reported second quarter 2019 financial results.
Epizyme, Inc. announced that Robert Bazemore, president and chief executive officer, will present at the Wedbush PacGrow 2019 Healthcare Conference on Tuesday, Aug. 13, 2019 at 10:55 a.m. ET in New York City.
Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that the U.S. Food and Drug Administration has accepted for filing the company’s New Drug Application for accelerated approval of tazemetostat, its lead investigational agent.
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced the appointment of Paolo Tombesi as chief financial officer, effective August 2019.
Epizyme Reports Updated Data from Phase 2 Trial of Tazemetostat in Patients with Relapsed or Refractory Follicular Lymphoma
Epizyme, Inc. reported positive interim data from an ongoing Phase 2 trial of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
Epizyme, Inc. 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.
Epizyme Reports Updated Data from Phase 2 Trial of Tazemetostat for Epithelioid Sarcoma at 2019 ASCO Annual Meeting
New Clinical Data Presented Today Included in Recently Submitted NDA to FDA
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
Submission Follows Productive Pre-NDA Meeting and Marks On-time Execution of First of Two NDA Submissions Planned for 2019