SETD2

Epizyme Reports First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 10, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Mutation, GAAP, Multiple myeloma, National Cancer Institute, Safety, Lymphoid leukemia, Ageing, SEC, Nausea, Pain, EZH2, Company, Private Securities Litigation Reform Act, Lists of diseases, NCCN, Patient, SETD2, FDA, SG, Workforce, Follicular lymphoma, Disease, B-cell lymphoma, Constipation, Epithelioid sarcoma, Vomiting, Methylation, Medicare, RNA, Fatigue, Upper respiratory tract infection, Neoplasm, Medicare Part D, Physician, Time, Bristol Myers Squibb, DNA, Sale, MM, RNA splicing, Journal of the National Comprehensive Cancer Network, Arm, COVID-19, Appetite, Nasdaq, Celgene, Form, DLBCL, Depreciation, Abdominal pain, Review, Webcast, Adult, Cancer, Form 10-K, Lymphoma, Society, ID, B cell, Pharmaceutical industry, Medical device, Video game, Lithium, Bank, Kerosene

Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, today reported first quarter 2022 financial results and provided a business update.

Key Points: 
  • Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, today reported first quarter 2022 financial results and provided a business update.
  • Commercial demand increased 16% in the first quarter of 2022 versus the fourth quarter of 2021 levels while total demand (commercial demand and free goods supplied through the patient assistance program) in the first quarter of 2022 was similar to fourth quarter 2021 levels.
  • Epizyme, in collaboration with LYSA, anticipates presenting top-line results from the Phase 2 portion of the study in the second half of 2022.
  • Non-GAAP adjusted R&D expenses were $27.8 million for the first quarter of 2022, compared to $30.3 million for the first quarter of 2021.

Repare Therapeutics Presents Updated Clinical Data from the Ongoing Phase 1/2 TRESR Study of RP-3500 Monotherapy in Solid Tumors at the 2022 AACR Annual Meeting

Retrieved on: 
Monday, April 11, 2022
Biotechnology, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Genetics, Science, Clinical Trials, Treatment, Private Securities Litigation Reform Act, Therapy, Clonal hematopoiesis, Research, Risk, SEC, Head, Progression-free survival, Medical director, MBBS, Neoplasm, Ataxia–telangiectasia, MD, SETD2, Data, AMF, ATM, CPSA, CRISPR, Security (finance), ORR, BRCA2, Anemia, CHIP, Institute, U.S. Securities and Exchange Commission, Department, MD Anderson Cancer Center, PKMYT1, PARP, Talazoparib, DNA, Forward-looking statement, LOF, Clinical trial, Pharmacokinetics, RECIST, FRCP, Doctor of Philosophy, ATR, Ovarian cancer, STEP2, Associate professor, Melanoma, Patient, Company, BRCA1, Genome, Parpi, RAD51C, Platinum, PFS, CA125, Safety, CBR, COVID-19, Breast cancer, Division, Pharmaceutical industry, Medical imaging, Reparenting

Our comprehensive new dataset shows ATM loss of function as a compelling opportunity to offer durable clinical benefit to patients with genetically defined tumors.

Key Points: 
  • Our comprehensive new dataset shows ATM loss of function as a compelling opportunity to offer durable clinical benefit to patients with genetically defined tumors.
  • The Company will subsequently host a conference call today, April 11th at 6:30 p.m. Eastern Time to discuss the latest results from the TRESR trial.
  • Key highlights from the data presented at the 2022 AACR Annual Meeting include:
    RP-3500 monotherapy continues to appear safe and well tolerated.
  • Clinical benefit was also observed in patients with tumors harboring BRCA1 and BRCA2 genomic alterations, as predicted by SNIPRx.

Epizyme Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 1, 2022
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Lists of diseases, SETD2, Abdominal pain, Fast Track, RNA, EZH2, DLBCL, ID, COVID-19, Company, SG, Private Securities Litigation Reform Act, Nasdaq, Form 10-K, Multiple myeloma, Vomiting, Upper respiratory tract infection, Nausea, Sale, Safety, Disease, Adult, Review, Bristol Myers Squibb, Food, Constipation, RNA splicing, Fatigue, Roche, B-cell lymphoma, Orphan drug, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pain, Appetite, Neoplasm, MCRPC, Mutation, Celgene, DNA, Methylation, Patient, Depreciation, Epithelioid sarcoma, Physician, Webcast, Follicular lymphoma, Rituximab, Ageing, Lymphatic system, MM, Lymphoid leukemia, FDA, Cancer, GAAP, SEC, Pharmaceutical industry, Video game, Lithium, Bank

TAZVERIK commercial net sales in the fourth quarter of 2021 were $7.4 million, representing an increase of approximately 42% when compared to $5.2 million in the third quarter of 2021.

Key Points: 
  • TAZVERIK commercial net sales in the fourth quarter of 2021 were $7.4 million, representing an increase of approximately 42% when compared to $5.2 million in the third quarter of 2021.
  • Total end user demand in the fourth quarter of 2021 represented a 14% increase over third quarter 2021 levels.
  • Fourth Quarter and Full Year 2021 Financial Results:
    Cash Position: Cash, cash equivalents and marketable securities were $176.8 million as of December 31, 2021.
  • Revenue: Total revenue for the fourth quarter of 2021 was $11.6 million, compared to $4.5 million for the fourth quarter of 2020.

Epizyme Provides Business Highlights, Preliminary Fourth Quarter and Full Year 2021 Financials and Clinical Trial Updates

Retrieved on: 
Monday, January 10, 2022
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Prostate, EZH2, Pain, DNA, Follicular lymphoma, R2, B-cell lymphoma, Constipation, FDA, Lists of diseases, BID, Appetite, American Society of Hematology, Cyclophosphamide, Mutation, Multiple myeloma, Bristol Myers Squibb, ASH, Sale, Prednisolone, RNA, Private Securities Litigation Reform Act, Company, Neoplasm, Celgene, Upper respiratory tract infection, RNA splicing, Adoption, Depreciation, SEC, Safety, Epithelioid sarcoma, MCRPC, Fatigue, Nausea, Patient, Vomiting, Physician, SETD2, GAAP, Abdominal pain, Rituximab, Fast Track, Nasdaq, Adult, COVID-19, Disease, Ageing, Lymphatic system, Cancer, MM, DLBCL, Lymphoid leukemia, Review, Doxorubicin, Vincristine, Form 10-K, Methylation, Society, Pharmaceutical industry, Medical device, Medical imaging, Medicine, Hematology, Non-GAAP Financial Measures, TAZVERIK® (tazemetostat), EZM0414, Epizyme, Inc., NON-GAAP FINANCIAL MEASURES, TAZVERIK® (TAZEMETOSTAT), EZM0414, EPIZYME, INC.

For Epizyme, 2021 was defined by key organizational changes that reduced our overall operating expenses while we accelerated TAZVERIK commercial adoption.

Key Points: 
  • For Epizyme, 2021 was defined by key organizational changes that reduced our overall operating expenses while we accelerated TAZVERIK commercial adoption.
  • TAZVERIK commercial net sales in the fourth quarter of 2021 are expected to be between $7.0-7.5 million, representing an increase of approximately 35% when compared to $5.2 million in the third quarter of 2021.
  • Total end user demand in the fourth quarter of 2021 is expected to represent at least a 14% increase over third quarter 2021 levels.
  • Epizyme also shared preclinical data on EZM0414 along with the SET-101 Phase 1/1b clinical trial design at the 2021 ASH conference.

Epizyme Presents Preclinical Data and Phase 1/1b Trial Design on the Company’s SETD2 Inhibitor, EZM0414, at the 2021 ASH Annual Meeting

Retrieved on: 
Saturday, December 11, 2021
Biotechnology, Pharmaceutical, Health, Other Health, B-cell lymphoma, Time, RNA splicing, DNA, Doctor of Philosophy, Pharmacokinetics, ASH, Epigenetics, COVID-19, Patient, Futility, Lymphoid leukemia, Abstract, Growth, Cancer, Physician, RNA, Company, MM, DLBCL, Multiple myeloma, Private Securities Litigation Reform Act, Follicular lymphoma, Development, Form 10-K, Research, Safety, Methylation, SEC, Review, Society, Nasdaq, Adult, SETD2, MD, Pharmaceutical industry, Vaccine, Medical imaging, EZM0414, Epizyme, Inc., EZM0414, EPIZYME, INC.

The data and the design were presented today at the 2021 American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • The data and the design were presented today at the 2021 American Society of Hematology (ASH) Annual Meeting.
  • This work has increased our understanding of the potential for EZM0414 in B cell malignancies and formed the basis for our first-in-human studies, beginning with our SET-101 Phase 1/1b trial.
  • Epigenetic mutations and dependencies have been identified in B cell malignancies, including MM and DLBCL, providing therapeutic rationale for epigenetic inhibitors in these tumor types.
  • These preclinical data form the basis for SET-101, the Companys Phase 1/1b clinical study (Abstract # 1679 ), which is designed to evaluate the safety and determine the optimal dose of EZM0414.

Epizyme to Present New Data from Its Oncology Portfolio at 2021 American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, December 2, 2021
Biotechnology, Pharmaceutical, Health, Other Health, Patient, EZH2, Joint Planning and Development Office, Review, Safety, Data analysis, Lymphatic system, Private Securities Litigation Reform Act, Company, MS, Cancer, Bristol Myers Squibb, SEC, Multiple myeloma, Blood, Department, COVID-19, Physician, R2, Nasdaq, Adult, B-cell lymphoma, ASH, Duke Cancer Institute, DLBCL, Hematology, Society, Lymphoid leukemia, Form 10-K, Associate professor, Celgene, Division, SETD2, Follicular lymphoma, Pharmaceutical industry

Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets, today announced that new data from across its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11 to 14, 2021 in Atlanta, Georgia.

Key Points: 
  • Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets, today announced that new data from across its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11 to 14, 2021 in Atlanta, Georgia.
  • These data provided the rationale for the SET-101 study, the first-in-human Phase 1/1b clinical trial designed to evaluate safety and determine the optimal dose of EZM0414.
  • The Company aspires to change the standard-of-care for patients and physicians by developing medicines with fundamentally new mechanisms of action.
  • 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.

Epizyme Reports Third Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 9, 2021
Research, FDA, Genetics, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Society, Cancer, Traction, European Society for Medical Oncology, SG, Constipation, Congress, Follicular lymphoma, COVID-19, ESMO, Workflow, Rituximab, Pain, Upper respiratory tract infection, Lenalidomide, Webcast, Oncology, Review, Fast Track, Quest Diagnostics, Safety, Form 10-K, MCRPC, SETD2, Cyclophosphamide, Growth, Vomiting, GAAP, Doxorubicin, Lymphoid leukemia, Patient, FDA, Adult, Lymphatic system, Private Securities Litigation Reform Act, Organization, EZH2, Vincristine, Mutation, Prednisolone, ID, Fatigue, Sale, Multiple myeloma, SEC, Relapse, Lists of diseases, Nausea, Prostate, Commercial, Ageing, U.S. FDA, Appetite, ASH, Depreciation, Neoplasm, Company, Awareness, Physician, Nasdaq, Abdominal pain, IND, Fine chemical, Pharmaceutical industry, Medical device, Coal, Video game, Lithium, Bank, Kerosene, Non-GAAP Financial Measures, TAZVERIK® (tazemetostat), Epizyme, Inc., NON-GAAP FINANCIAL MEASURES, TAZVERIK® (TAZEMETOSTAT), EPIZYME, INC.

Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today reported its third quarter 2021 financial results and business update.

Key Points: 
  • Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today reported its third quarter 2021 financial results and business update.
  • In terms of TAZVERIK commercial performance, total end user demand grew 22% this quarter versus the second quarter.
  • Total end user demand increased by 22% in the third quarter over the second quarter of 2021, driven primarily by sales in FL.
  • Revenue: Total revenue for the third quarter of 2021 was $5.2 million, compared to $3.6 million for the third quarter of 2020.

Epizyme Receives Fast Track Designation from U.S. FDA and Announces Initiation of Phase 1/1b Study of its Novel SETD2 Inhibitor, EZM0414

Retrieved on: 
Thursday, November 4, 2021
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In addition, the Company has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414.

Key Points: 
  • In addition, the Company has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414.
  • Following this dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.
  • SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis.
  • The designation enables early and frequent communication between FDA and a product sponsor throughout the drug development and review process.

Epizyme Announces CEO Succession

Retrieved on: 
Monday, August 9, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Follicular lymphoma, Board of directors, Acquisition, Cancer, Mutation, Growth, Review, GSK, Oncology, Â, U.S. FDA, Leadership, COVID-19, CEO, GlaxoSmithKline, Lymphatic system, Bortezomib, Private Securities Litigation Reform Act, Pain, Adult, Form 10-K, EZH2, Abdominal pain, Constipation, Board, Senior, ES, SETD2, Neoplasm, Time, Fatigue, Medication, ID, Lists of diseases, Ageing, Patient, SEC, Marketing, McKesson Corporation, Vomiting, Ovarian cancer, Company, Adoption, Upper respiratory tract infection, Multiple myeloma, FDA, Epithelioid sarcoma, Appetite, Nasdaq, Nausea, Takeda Oncology, Physician, Management, Pharmaceutical industry, Medicine, Epizyme, Inc., TAZVERIK® (tazemetostat), EPIZYME, INC., TAZVERIK® (TAZEMETOSTAT)

Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies today announced its Chief Executive Officer (CEO) succession plan, with industry veteran Grant Bogle succeeding Robert Bazemore, as President and CEO.

Key Points: 
  • Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies today announced its Chief Executive Officer (CEO) succession plan, with industry veteran Grant Bogle succeeding Robert Bazemore, as President and CEO.
  • David M. Mott, an Epizyme Board member since 2009 and current Chairman said, On behalf of the entire Board of Directors at Epizyme, we welcome Grant into the CEO role.
  • to discuss its second quarter 2021 financial results, as well as the CEO succession plan.
  • By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them.

Epizyme Announces Preclinical and Clinical Data to be Presented in Oral and Poster Sessions at Upcoming Medical Conferences in June

Retrieved on: 
Wednesday, May 12, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, SETD2, EZH2, Tazemetostat

\xe2\x80\x9cAs our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK\xc2\xae (tazemetostat).

Key Points: 
  • \xe2\x80\x9cAs our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK\xc2\xae (tazemetostat).
  • SETD2 is a histone methyltransferase, like EHZ2, and plays multiple key roles in cellular processes and cancer.
  • Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials(s).
  • By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them.