Tazemetostat

HUTCHMED Completes Patient Enrollment of a Bridging Study of Tazemetostat in Patients with Relapsed/Refractory Follicular Lymphoma in China

Retrieved on: 
Tuesday, September 12, 2023

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China.

Key Points: 
  • HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China.
  • The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (“R/R FL”).
  • The primary objective is to evaluate the objective response rate (“ORR”) of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH21 mutations (Cohort 1).
  • HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

HUTCHMED Initiates a Bridging Study of Tazemetostat in Patients with Relapsed/Refractory Follicular Lymphoma in China

Retrieved on: 
Monday, August 1, 2022

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a bridging study of tazemetostat in China.

Key Points: 
  • HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a bridging study of tazemetostat in China.
  • The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (R/R FL).
  • The primary objective is to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have mutations in EZH21 (Cohort 1).
  • The most common (20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Epizyme, Inc. (Nasdaq - EPZM), USA Truck, Inc. (Nasdaq - USAK), Zendesk, Inc. (NYSE - ZEN), F-star Therapeutics, Inc. (Nasdaq - FSTX)

Retrieved on: 
Tuesday, July 5, 2022

BALA CYNWYD, Pa., July 05, 2022 (GLOBE NEWSWIRE) -- Brodsky & Smith reminds investors of the following investigations.

Key Points: 
  • BALA CYNWYD, Pa., July 05, 2022 (GLOBE NEWSWIRE) -- Brodsky & Smith reminds investors of the following investigations.
  • If you own shares and wish to discuss the investigation, contact Jason Brodsky ( [email protected] ) or Marc Ackerman ( [email protected] ) at 855-576-4847.
  • Each CVR will entitle its holder to deferred cash payments of $0.30 per CVR payable upon certain achievement with respect to net sales of Tazverik.
  • Brodsky & Smith is a litigation law firm with extensive expertise representing shareholders throughout the nation in securities and class action lawsuits.

Global $1.2 Billion EZH2 Inhibitor Market Opportunity, Sales & Clinical Trials Insights to 2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 5, 2021

The "Global EZH2 Inhibitor Market Opportunity, Sales & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global EZH2 Inhibitor Market Opportunity, Sales & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com's offering.
  • Global EZH2 inhibitor drug market will grow with a CAGR of more than 110% and is expected to surpass US$ 1 Billion by 2026.
  • US is expected to dominate the global EZH2 inhibitor drug market due to high adoption rates, increasing research and development activities as well as increase in prevalence of cancer.
  • "Global EZH2 Inhibitor Market Opportunity, Sales & Clinical Trials Insight 2026" Report Highlights:
    EZH2 Inhibitor Clinical Pipeline Overview By Company, Indication & Phase
    EZH2 Inhibitor in Clinical Trials: 7 Drugs

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

\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.

Epizyme Announces Date of First Quarter 2021 Financial Results

Retrieved on: 
Thursday, April 29, 2021

These indications are approved under accelerated approval based on overall response rate and duration of response.

Key Points: 
  • 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).
  • 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 .\nTAZVERIK\xc2\xae is a registered trademark of Epizyme, Inc.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210429005135/en/\n"

Epizyme Announces Date of Fourth Quarter and Full Year 2020 Financial Results and Participation in Upcoming Investor Conferences

Retrieved on: 
Tuesday, February 16, 2021

Details of the events are as follows:

Key Points: 
  • Details of the events are as follows:
    Fourth Quarter and Full Year 2020 Financial Results: Management will host a conference call and webcast to discuss its fourth quarter and full year 2020 financial results on Tuesday, February 23, 2021 at 8:00 a.m.
  • To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 3719819.
  • By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them.
  • TAZVERIK is a registered trademark of Epizyme, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005096/en/

Roche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma

Retrieved on: 
Friday, June 19, 2020

INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of thecobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK(tazemetostat), developed by Epizyme, Inc.

Key Points: 
  • INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of thecobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK(tazemetostat), developed by Epizyme, Inc.
  • "The approval of the cobas EZH2 Mutation Test underscores Roche's personalised healthcare strategy to provide innovative diagnostic tools for physicians and their patients,"said John Palma, Chief Medical Officer of Roche Sequencing Solutions.
  • The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year.
  • The cobas EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK (tazemetostat), in accordance with the approved therapeutic product labeling.

Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma

Retrieved on: 
Wednesday, December 18, 2019

Tazemetostat is an oral, first-in-class EZH2 inhibitor being developed for a range of cancers and treatment settings.

Key Points: 
  • Tazemetostat is an oral, first-in-class EZH2 inhibitor being developed for a range of cancers and treatment settings.
  • We are very pleased to have submitted this NDA in hopes of bringing tazemetostat to FL patients and their physicians, said Dr. Shefali Agarwal, chief medical officer of Epizyme.
  • We are grateful to the patients and medical teams who have meaningfully contributed to advancing tazemetostat to this stage.
  • Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.