EPZM Epizyme Inc.

13.26
+0.14  (+1%)
Previous Close 13.12
Open 13
52 Week Low 9.735
52 Week High 27.82
Market Cap $1,345,601,820
Shares 101,478,267
Float 75,108,528
Enterprise Value $1,135,487,863
Volume 2,854,868
Av. Daily Volume 948,475
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Drug Pipeline

Drug Stage Notes
Tazemetostat
Follicular lymphoma
Approved
Approved
FDA approval announced June 18, 2020.
Tazemetostat + Atezolizumab
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Phase 1
Phase 1
Phase 1b enrollment complete.
Tazemetostat
Epithelioid Sarcoma
Approved
Approved
FDA approval announced January 23, 2020.
Tazemetostat
Adult patients with mesothelioma characterized by BAP1 loss-of-function
Phase 2
Phase 2
Phase 2 dosing commenced August 2016. Noted April 23, 2018 that all Tazemetostat trials have been placed on partial clinical hold.

Latest News

  1. Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that Robert Bazemore, president and chief executive officer, will participate in a fireside chat during the Morgan Stanley 18th Annual Global Healthcare Conference on Monday, Sept. 14, 2020 at 3:45 p.m. ET.

    A live webcast will be available in the investor section of the company's website at www.epizyme.com, and will be archived for 60 days following the event.

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines…

    Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that Robert Bazemore, president and chief executive officer, will participate in a fireside chat during the Morgan Stanley 18th Annual Global Healthcare Conference on Monday, Sept. 14, 2020 at 3:45 p.m. ET.

    A live webcast will be available in the investor section of the company's website at www.epizyme.com, and will be archived for 60 days following the event.

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

    TAZVERIK® is a registered trademark of Epizyme, Inc. For full prescribing information, please visit TAZVERIK.com.

    View Full Article Hide Full Article
  2. TAZVERIK® Approved for Multiple Cancer Indications; Executing Well on Commercial Launches for TAZVERIK in Epithelioid Sarcoma and Follicular Lymphoma

    Conference Call to be Held Today, August 4 at 8:30 a.m. ET

    Epizyme, (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today provided business and portfolio updates and reported second quarter 2020 financial results.

    "With back-to-back FDA approvals for TAZVERIK over the course of the last six months, we have a significant opportunity to provide a safe and effective new therapeutic option to patients in need," said Robert Bazemore, president and chief executive officer of Epizyme. "As we move into the second…

    TAZVERIK® Approved for Multiple Cancer Indications; Executing Well on Commercial Launches for TAZVERIK in Epithelioid Sarcoma and Follicular Lymphoma

    Conference Call to be Held Today, August 4 at 8:30 a.m. ET

    Epizyme, (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today provided business and portfolio updates and reported second quarter 2020 financial results.

    "With back-to-back FDA approvals for TAZVERIK over the course of the last six months, we have a significant opportunity to provide a safe and effective new therapeutic option to patients in need," said Robert Bazemore, president and chief executive officer of Epizyme. "As we move into the second half of the year, we are focused on the successful execution of our launches and all other aspects of our business. Despite the evolving COVID-19 situation, our commercial launches are proceeding very well, and our in-house and clinical collaboration efforts to evaluate tazemetostat in additional combinations and indications remain on track. We have delivered on the major corporate objectives we set for the first half of 2020, and we look forward to the continued advancement of our programs in order to help as many patients as possible."

    Recent Progress

    • TAZVERIK Approval and Commercial Launch Underway in Relapsed or Refractory Follicular Lymphoma (FL): TAZVERIK was granted accelerated approval and became commercially available to eligible patients on June 18, 2020. Epizyme's field team began engaging immediately with the FL prescribing community, with the first prescription filled on June 25, 2020, and initial feedback from physicians and payors on this approval and the TAZVERIK label has been highly positive.
    • TAZVERIK Added to NCCN Clinical Practice Guidelines for FL: Shortly after the FDA approval of TAZVERIK in FL, the National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for FL to include TAZVERIK as a recommended category 2A treatment for patients with relapsed or refractory FL. The NCCN Guidelines are the recognized clinical standard for cancer care by U.S. healthcare providers and payors and are maintained by a committee of expert physicians from leading U.S. cancer centers.
    • Continued Commercial Execution for TAZVERIK in Epithelioid Sarcoma (ES): TAZVERIK became commercially available to patients on February 1, 2020, following its accelerated approval on January 23, 2020, for the treatment of metastatic or locally advanced ES. Amidst the COVID-19 situation, the field-based teams are executing well and leveraging virtual and other non-personal methods to continue to engage with customers. At the end of the second quarter, TAZVERIK had generated total net product sales of $3.5 million since its launch, primarily comprised of sales in ES.
    • Expansion Development of Tazemetostat Remains on-Track: Epizyme's expansion program to further investigate tazemetostat's therapeutic potential in earlier lines of therapy for FL, including several combination regimens with anti-cancer therapies, as well as in other cancer indications and combinations, is advancing as planned and remains on track.

    Financial Guidance

    Based on its current operating plans, Epizyme continues to believe that its existing cash, cash equivalents and marketable securities will fund the company's operations into at least 2022. The company expects its non-GAAP adjusted cash-based operating expenses for 2020 will be between $235 and $255 million, which excludes any milestone payments paid by the company and non-cash items, such as stock-based compensation and amortization or depreciation of intangibles.

    Second Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $322.1 million as of June 30, 2020, as compared to $376.5 million as of March 31, 2020.
    • Revenue: Total revenue for the second quarter of 2020 was $2.5 million, comprised of $2.2 million in net sales of TAZVERIK in the U.S. and $0.2 million in collaboration revenue, compared to $1.4 million in Q1 2020, comprised of $1.3 million in net sales of TAZVERIK in the U.S. following its launch in January 2020 and $0.1 million in collaboration revenue.
    • Operating Expenses: Total GAAP operating expenses were $60.0 million for the second quarter of 2020, compared to $52.7 million for the first quarter of 2020. Total non-GAAP adjusted operating expenses were $50.9 million for the second quarter of 2020, compared to $45.7 million for the first quarter of 2020.
      • R&D expenses: GAAP R&D expenses were $26.4 million for the second quarter of 2020, compared to $25.2 million for the first quarter of 2020, while non-GAAP adjusted R&D expenses were $23.4 million for the second quarter of 2020, compared to $22.9 million for the first quarter of 2020. The increase was primarily due to expenses related to the support of Epizyme's clinical trials and development candidates.
      • SG&A expenses: GAAP SG&A expenses were $32.7 million for the second quarter of 2020, compared to $26.9 million for the first quarter of 2020, while non-GAAP adjusted SG&A expenses were $27.1 million for the second quarter of 2020, compared to $22.5 million for the first quarter of 2020. The increase was primarily due to expenses related to the company's expansion of its infrastructure to support the launch in FL.
    • Eisai Milestone Payments: Following the approval of TAZVERIK in the FL indication, the final milestone owed to Eisai of $25 million under the collaboration agreement was paid and funded by the third and final tranche of the $70 million loan facility with Pharmakon Advisors.
    • Net Loss (GAAP): Net loss attributable to common stockholders was $58.5 million, or $0.58 per share, for the second quarter of 2020, compared to $50.9 million, or $0.51 per share, for the first quarter of 2020.

    A reconciliation of cash-based financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.

    Conference Call Information

    Epizyme will host a conference call today, August 4, at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5081295. A webcast will be available in the investor section of the company's website at www.epizyme.com, and will be archived for 60 days following the call.

    About Non-GAAP Financial Measures

    In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP R&D expenses on a historical basis and non-GAAP SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense, amortization or depreciation of intangibles and milestone payments related to TAZVERIK that are payable under the company's collaboration agreement with Eisai Pharmaceuticals. The company's management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company's inability to predict with reasonable certainty the amount of future stock-based compensation expense.

    About TAZVERIK

    TAZVERIK is a methyltransferase inhibitor indicated 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.
    • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
    • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

    These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

    View the U.S. Full Prescribing Information here: Epizyme.com

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match 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: the successful launch of commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory 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; the impact of the COVID-19 pandemic on the company's business, results of operations and financial condition; 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 success of tazemetostat or 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.

    TAZVERIK® is a registered trademark of Epizyme, Inc.

    EPIZYME, INC

    CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)

    (Amounts in thousands)

     
     

    June 30,

    2020

    December 31,

    2019

    Consolidated Balance Sheet Data:

    Cash and cash equivalents

    $

    117,152

    $

    139,482

    Marketable securities

     

    204,910

     

    241,605

    Intangible assets, net

     

    49,079

     

    -

    Total assets

     

    427,383

     

    424,589

    Total current liabilities

     

    30,655

     

    34,386

    Deferred revenue

     

    3,933

     

    3,806

    Long-term debt, net of debt discount

     

    68,464

     

    23,309

    Liability related to sale of future royalties

     

    13,388

     

    12,793

    Total stockholders' equity

     

    293,363

     

    331,137

    EPIZYME, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (Amounts in thousands except per share data)

     

     

    Three Months Ended

    June 30

    Six Months Ended

    June 30

     

    Three Months Ended

    March 31

     

    2020

    2019

    2020

    2019

     

    2020

    Revenues

     

     

    Product revenue, net

     

    $

    2,234

     

    $

    -

     

    $

    3,519

     

    $

    -

     

     

    $

    1,284

     

    Collaboration revenue

     

     

    233

     

     

    5,900

     

     

    303

     

     

    13,791

     

     

     

    70

     

    Total revenue

     

     

    2,467

     

     

    5,900

     

     

    3,822

     

     

    13,791

     

     

     

    1,354

     

     

     

     

     

     

     

    Operating expenses

     

     

     

    Cost of product revenue

     

     

    1,022

     

     

    -

     

     

    1,637

     

     

    -

     

     

     

    614

     

    Research and development

     

     

    26,352

     

     

    40,907

     

     

    51,516

     

     

    67,803

     

     

     

    25,163

     

    Selling, general and administrative

     

     

    32,659

     

     

    15,698

     

     

    59,584

     

     

    27,684

     

     

     

    26,927

     

    Total operating expenses

     

     

    60,033

     

     

    56,605

     

     

    112,737

     

     

    95,487

     

     

     

    52,704

     

    Operating loss

     

     

    (57,566

    )

     

    (50,705

    )

     

    (108,915

    )

     

    (81,696

    )

     

     

    (51,350

    )

    Other income, net:

     

     

     

    Interest (expense) income, net

     

     

    (569

    )

     

    2,253

     

     

    187

     

     

    3,911

     

     

     

    756

     

    Other expense, net

     

     

    (15

    )

     

    (13

    )

     

    (64

    )

     

    (19

    )

     

     

    (48

    )

    Non-cash interest expense related to sale of future

    royalties

     

     

    (301

    )

     

    -

     

     

    (596

    )

     

    -

     

     

     

    (295

    )

    Other (expense) income, net:

     

     

    (885

    )

     

    2,240

     

     

    (473

    )

     

    3,892

     

     

     

    413

     

    Loss before income taxes

     

     

    (58,451

    )

     

    (48,465

    )

     

    (109,388

    )

     

    (77,804

    )

     

     

    (50,937

    )

    Income provision

     

     

    -

     

     

    -

     

     

    -

     

     

    -

     

     

     

    -

     

    Net loss

     

    $

    (58,451

    )

    $

    (48,465

    )

    $

    (109,388

    )

    $

    (77,804

    )

     

    $

    (50,937

    )

     

     

     

     

     

     

    Reconciliation of net loss to net loss attributable to common stockholders

     

     

     

    Net loss

     

    $

    (58,451

    )

    $

    48,465

    )

    $

    (109,388

    )

    $

    (77,804

    )

     

    $

    (50,937

    )

    Accretion of convertible preferred stock

     

     

    -

     

     

    -

     

     

    -

     

     

    (2,940

    )

     

     

    -

     

    Net loss attributable to common stockholders

     

    $

    (58,451

    )

    $

    (48,465

    )

    $

    (109,388

    )

    $

    (80,744

    )

     

    $

    (50,937

    )

    Net loss per share attributable to common stockholders - basic and diluted

     

    $

    (0.58

    )

    $

    (0.53

    )

    $

    (1.09

    )

    $

    (1.04

    )

     

    $

    (0.51

    )

     

     

     

    Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted

     

     

    101,104

     

     

    90,876

     

     

    100,360

     

     

    77,315

     

     

     

    99,616

     

    EPIZYME, INC.

    Reconciliation of Selected GAAP Measures to Non-GAAP Measures (UNAUDITED)

    (Amounts in thousands)

         

     

    Three Months Ended

    June 30

    Six Months Ended

    June 30

     

    Three Months Ended

    March 31

    Reconciliation of GAAP to Non-GAAP Cost of Product Revenue

     

    2020

    2019

     

    2020

    2019

     

    2020

    GAAP Cost of Product Revenue

     

    $

    1,022

     

    $

    -

     

     

    $

    1,637

     

    $

    -

     

     

    $

    614

     

    Less: Depreciation and Amortization

     

     

    (623

    )

     

    -

     

     

     

    (921

    )

     

    -

     

     

     

    (298

    )

    Non-GAAP Cost of Product Revenue

     

    $

    399

     

    $

    -

     

     

    $

    716

     

    $

    -

     

     

    $

    316

     

         

     

         

     

    Reconciliation of GAAP to Non-GAAP Research and Development

         

     

    GAAP Research and Development

     

    $

    26,352

     

    $

    40,907

     

     

    $

    51,516

     

    $

    67,803

     

     

    $

    25,163

     

    Less: Stock-Based Compensation Expenses

     

     

    (2,803

    )

     

    (1,732

    )

     

     

    (4,966

    )

     

    (2,897

    )

     

     

    (2,162

    )

    Less: Depreciation and Amortization

     

     

    (130

    )

     

    (157

    )

     

     

    (268

    )

     

    (315

    )

     

     

    (138

    )

    Less: Eisai R&D Milestone Expense

     

     

    -

     

     

    (10,000

    )

     

     

    -

     

     

    (10,000

    )

     

     

    -

     

    Non-GAAP Research and Development

     

    $

    23,419

     

    $

    29,018

     

     

    $

    46,282

     

    $

    54,591

     

     

    $

    22,863

     

         

     

    Reconciliation of GAAP to Non-GAAP Selling, General and Administrative:

         

     

    GAAP Selling, General and Administrative

     

    $

    32,659

     

    $

    15,698

     

     

    $

    59,584

     

    $

    27,684

     

     

    $

    26,927

     

    Less: Stock-Based Compensation Expenses

     

     

    (5,488

    )

     

    (2,996

    )

     

     

    (9,836

    )

     

    (5,042

    )

     

     

    (4,348

    )

    Less: Depreciation and Amortization

     

     

    (100

    )

     

    (52

    )

     

     

    (193

    )

     

    (101

    )

     

     

    (93

    )

    Non-GAAP Selling, General and Administrative

     

    $

    27,071

     

    $

    12,650

     

     

    $

    49,555

     

    $

    22,541

     

     

    $

    22,486

     

         

     

    Reconciliation of GAAP to Non-GAAP Operating Expenses

         

     

    GAAP Operating Expenses

     

    $

    60,033

     

    $

    56,605

     

     

    $

    112,737

     

    $

    95,487

     

     

    $

    52,704

     

    Less: Stock-Based Compensation Expenses

     

     

    (8,291

    )

     

    (4,728

    )

     

     

    (14,802

    )

     

    (7,939

    )

     

     

    (6,510

    )

    Less: Depreciation and Amortization

     

     

    (853

    )

     

    (209

    )

     

     

    (1,382

    )

     

    (416

    )

     

     

    (529

    )

    Less: Eisai R&D Milestone Expense

     

     

    -

     

     

    (10,000

    )

     

     

    -

     

     

    (10,000

    )

     

     

    -

     

    Non-GAAP Operating Expenses

     

    $

    50,889

     

    $

    41,668

     

     

    $

    96,553

     

    $

    77,132

     

     

    $

    45,665

     

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  3. Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that management will host a conference call and webcast to discuss its second quarter 2020 financial results and other business highlights and will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference. Details of both events are as follows:

    • Second Quarter 2020 Financial Results: Management will host a conference call and webcast to discuss its second quarter 2020 financial results and other business highlights on Tuesday, Aug. 4, 2020 at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer…

    Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that management will host a conference call and webcast to discuss its second quarter 2020 financial results and other business highlights and will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference. Details of both events are as follows:

    • Second Quarter 2020 Financial Results: Management will host a conference call and webcast to discuss its second quarter 2020 financial results and other business highlights on Tuesday, Aug. 4, 2020 at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5081295.
    • 2020 Wedbush PacGrow Healthcare Virtual Conference: Epizyme will participate in the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, Aug. 11, 2020, with a company overview to be presented at 9:45 a.m. ET.

    Live webcasts will be available in the investor section of the company's website at www.epizyme.com, and will be archived for 60 days following each event.

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

    TAZVERIK® is a registered trademark of Epizyme, Inc. For full prescribing information, please visit TAZVERIK.com.

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  4.  TAZVERIK Now Approved for Second Indication

    Commercial Organization Fully Prepared to Support Successful Launch in Follicular Lymphoma

    Company to Host Conference Call Today at 2:30 p.m. ET

    Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200618005820/en/

    TAZVERIK Logo

    TAZVERIK Logo

    • Adult patients with relapsed or refractory FL whose tumors are…

     TAZVERIK Now Approved for Second Indication

    Commercial Organization Fully Prepared to Support Successful Launch in Follicular Lymphoma

    Company to Host Conference Call Today at 2:30 p.m. ET

    Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200618005820/en/

    TAZVERIK Logo

    TAZVERIK Logo

    • Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
    • Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

    These indications were approved under accelerated approval with a priority review, based on overall response rate and duration of response in the company's Phase 2 clinical trial cohorts of FL patients with EZH2 mutations and wild-type EZH2. TAZVERIK received initial accelerated approval by FDA on January 23, 2020 for the treatment of adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

    "We are very pleased to be able to offer TAZVERIK as a treatment option for relapsed or refractory FL patients, which is the culmination of many years of work by our team," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "In our view, there remains no clear standard of care in the relapsed and/or refractory FL population as not all patients benefit from today's available therapies. Based on this label, physicians will have the ability to use their clinical discretion to prescribe TAZVERIK for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory. We are grateful to the many patients, physicians and medical teams who helped bring us to this important achievement."

    "Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma," said John P. Leonard, M.D., the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine, an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator in the Phase 1b/3 confirmatory trial for TAZVERIK for FL. "The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma."

    Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Epizyme is conducting a single global, randomized, adaptive confirmatory trial to evaluate the combination of TAZVERIK with "R2" (Revlimid® plus rituximab), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status, and the safety run-in portion is underway. In addition, Epizyme will conduct post-marketing commitments, including expanding its Phase 2 clinical trial cohort of FL patients with wild-type EZH2 who have been treated with at least one prior systemic treatment to enroll additional patients, in order to support a potential label expansion in the second-line relapsed and refractory setting in the future.

    "Despite witnessing numerous advancements for people with blood cancer over the past several years, many patients diagnosed with follicular lymphoma must still contend with relapse or recurrence as well the challenge of adverse events. For these reasons, and given that most patients manage their disease over a long time period, expanded treatment options can transform the patient experience and offer new hope," said Lymphoma Research Foundation chief executive officer, Meghan Gutierrez.

    "This accelerated approval is an incredible achievement for Epizyme, marking the second approval for TAZVERIK, the first FDA approved EZH2 inhibitor, in less than six months," said Robert Bazemore, president and chief executive officer of Epizyme. "Building off our successful commercial launch of TAZVERIK for epithelioid sarcoma earlier this year, we have seamlessly expanded our organization and are fully prepared to begin engaging physicians and to launch in FL. The ability to reach patients who need a new treatment like TAZVERIK is at the core of everything we do, and we are incredibly proud of this milestone and the ability to impact patients' lives."

    Phase 2 Follicular Lymphoma Cohort Efficacy and Safety Data

    The efficacy of TAZVERIK was evaluated in an open-label, single-arm, multi-center Phase 2 clinical trial (Study E7438-G000-101, NCT01897571) in patients with histologically confirmed FL whose disease had progressed following at least two prior systemic treatment regimens. Patients were enrolled into two cohorts: one cohort enrolled 45 patients with EZH2 activating mutations and a second cohort enrolled 54 patients with wild-type EZH2. All patients were treated with 800 mg of tazemetostat, administered orally twice a day. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) according to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria (Cheson 2007) as assessed by Independent Review Committee. Median duration of follow-up was 22 months for patients with EZH2 activating mutations and 36 months for patients with wild-type EZH2.

    Among the 45 FL patients with an EZH2 activating mutation who received TAZVERIK, the median age was 62 years (range 38 to 80); 42% were male; 42% had early progression following front-line therapy (POD24); and all had an ECOG performance status (PS) of 0 or 1. The median number of lines of prior systemic therapy was 2.0 (range 1 to 11); 49% were refractory to rituximab and 49% were refractory to their last therapy. In the 42 patients treated with at least 2 prior systemic therapies, the ORR (95% confidence interval) was 69% (53%, 82%), with 12% of patients achieving a complete response and 57% achieving a partial response. The median DOR was 10.9 months and ongoing.

    Among the 54 FL patients with wild-type EZH2 who received TAZVERIK, the median age was 61 years (range 36 to 87); 63% were male; 59% had POD24; and 91% had an ECOG PS of 0 or 1. The median number of lines of prior systemic therapy was 3.0 (range 1 to 8); 59% were refractory to rituximab and 41% were refractory to their last therapy. In the 53 patients treated with at least 2 prior systemic therapies, the ORR (95% confidence interval) was 34% (22%, 48%), with 4% of patients achieving a complete response and 30% achieving a partial response. The median DOR was 13.0 months.

    Serious adverse reactions, irrespective of attribution, occurred in 30% of patients receiving TAZVERIK. Serious adverse reactions in ≥2% of patients who received TAZVERIK were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

    Eight patients (8%) discontinued due to adverse reaction during the trial. There were no reported deaths on study, and no black box warnings or contraindications.

    View the U.S. Full Prescribing Information here: Epizyme.com

    About TAZVERIK

    TAZVERIK is a methyltransferase inhibitor indicated 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.
    • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
    • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

    These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

    Dosage and Administration

    The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    Secondary Malignancies

    • The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T LBL). Monitor patients long-term for the development of secondary malignancies.

    Embryo-Fetal Toxicity

    • Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.
    • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

    Adverse Reactions

    Epithelioid Sarcoma

    • In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

    Relapsed or Refractory Follicular Lymphoma

    • In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).

    Drug Interactions

    • Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
    • Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.
    • Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

    Lactation

    • Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

    Epizyme notes that Dr. Leonard is a paid consultant for Epizyme.

    Investor Conference Call

    Epizyme will host an investor conference call and webcast today at 2:30 p.m. ET. To participate in the call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 2277785. A live webcast will be available in the investor section of the company's website at www.epizyme.com. The webcast will be archived on the website for 60 days.

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match 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 tazemetostat will receive marketing approval for epithelioid sarcoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trial; 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 success of tazemetostat or 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.

    TAZVERIK™ is a trademark of Epizyme, Inc.

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  5. Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that multiple abstracts have been accepted for poster presentations during the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020.

    "We are pleased to participate in ASCO's virtual program, reporting the pooled data from the two Phase 2 study cohorts of tazemetostat for epithelioid sarcoma, which supported the approval of TAZVERIK™ in January, as well as a presentation of the trial design for our ongoing confirmatory trial in epithelioid sarcoma," said Dr. Shefali Agarwal. "We will also report the final data from our study of tazemetostat as…

    Epizyme, Inc. (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that multiple abstracts have been accepted for poster presentations during the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020.

    "We are pleased to participate in ASCO's virtual program, reporting the pooled data from the two Phase 2 study cohorts of tazemetostat for epithelioid sarcoma, which supported the approval of TAZVERIK™ in January, as well as a presentation of the trial design for our ongoing confirmatory trial in epithelioid sarcoma," said Dr. Shefali Agarwal. "We will also report the final data from our study of tazemetostat as a monotherapy for mesothelioma, originally presented at ASCO 2018, and early data from the Phase 1b portion of our trial of tazemetostat in pediatric patients with INI1-negative tumors. As we look ahead, 2020 is an important year for the commercialization of TAZVERIK, as well as advancing our tazemetostat clinical program in multiple additional cancer indications and combinations."

    All posters will be available online on May 29, 2020, and details of the abstracts are as follows:

    Title: Efficacy, safety, and immune priming effect of tazemetostat in patients with epithelioid sarcoma

    Authors: Mrinal M. Gounder, Silvia Stacchiotti, Patrick Schoffski, Gregory M. Cote, Victor M. Villalobos, Thierry M. Jahan, Tom Wei-Wu Chen, Ravin Ratan, Abha A. Gupta, Palma Dileo, Mark Agulnik, Antoine Italiano, Steven Attia, Olivier Mir, Joseph G. Pressey, Laura Sierra, Trupti Lingaraj, Jay Yang, Shefali Agarwal, Robin L. Jones

    Abstract: 11564

    Poster: 452

    Title: A phase Ib/III randomized, double-blind, placebo-controlled study of tazemetostat plus doxorubicin as frontline therapy for patients with advanced epithelioid sarcoma

    Authors: Shiraj Sen, Meredith A. McKean, Laura Sierra, Jessica Ainscough, Jay Yang, Anthony Hamlett, Tom Zimmerman, Melinda Merchant, Sant P. Chawla

    Abstract: TPS11573

    Poster: 461

    Title: Phase I study of tazemetostat, an enhancer of zeste homolog-2 inhibitor, in pediatric patients with relapsed/refractory integrase interactor 1-negative tumors

    Authors: Susan N. Chi, Franck Bourdeaut, Theodore W. Laetsch, Maryam Fouladi, Margaret E. Macy, Guy W. Makin, Neerav N. Shukla, Cynthia Wetmore, Ashley S. Margol, Michela Casanova, Lindsay B. Kilburn, Joanna Yi, Darren R. Hargrave, Geoffrey B. McCowage, Navin R. Pinto, David Ebb, Giles W. Robinson, Laura Sierra, Melinda Merchant, Karsten Nysom

    Abstract: 10525

    Poster: 412

    Title: Safety and efficacy of tazemetostat, an enhancer of zeste-homolog 2 inhibitor, in patients with relapsed or refractory malignant mesothelioma

    Authors: Marjorie G. Zauderer, Peter W. Szlosarek, Sylvestre Le Moulec, Sanjay Popat, Paul Taylor, David Planchard, Arnaud Scherpereel, Thierry M. Jahan, Marianna Koczywas, Martin Forster, Robert B. Cameron, Tobias Peikert, Evren K. Argon, Neil Michaud, Jay Yang, Vikram Kansra, Dean A. Fennell

    Abstract: 9058

    Poster: 251

    About Epizyme, Inc.

    Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. A supplemental New Drug Application is under Priority Review by the U.S. FDA for TAZVERIK for the treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. 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 tazemetostat will receive marketing approval for epithelioid sarcoma in other jurisdictions, full approval in the United States or approval in any other indication on a timely basis or at all, including approval of the company's sNDA for FL; uncertainties related to the impact on the company's business of the COVID-19 pandemic, including the commercial launch of TAZVERIK, ongoing and planned clinical trials and commercial and clinical supply of TAZVERIK; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory 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 success of tazemetostat or 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.

    TAZVERIK™ is a trademark of Epizyme, Inc.

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