CK1

TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL

Retrieved on: 
Friday, April 15, 2022
SLL, Immunity, Oncology Drug Advisory Committee, SPA, CLL, Chronic lymphocytic leukemia, Cell proliferation, Multiple sclerosis, PFS, Progression-free survival, COVID-19, LinkedIn, Adult, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASDAQ, Lymphocytosis, Investor, Food, Infection, Trial of the century, TG, Differentiable function, GLOBE, Sale, OS, Patient, PDUFA, Conference, Shanda, Sclerosis, Review, ODAC, Death, PI3K, CK1, NEW, UNITY, Ublituximab, RMS, Umbralisib, FDA, BLA, Attention, Risk, IRC, Acquisition, Overalls, Therapy, THE, Survival, Follicular lymphoma, Online gambling, Pharmaceutical industry, Medical device, Vaccine, Company, U2

The Companys decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

Key Points: 
  • The Companys decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.
  • The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed progression-free survival (PFS) vs. the control arm.
  • Based on the results of the UNITY-CLL trial, a BLA and sNDA were submitted to the FDA for U2 to treat patients with CLL/SLL.
  • To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call.

PI3K inhibitors Drug Pipeline Market Research Report 2022: Insights About 100+ Companies and 100+ Pipeline Drugs - ResearchAndMarkets.com

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Friday, February 11, 2022
Health, Pharmaceutical, Endometrial cancer, TG, CK1, Patient, Colorectal cancer, Cancer, CLL, NHL, Rigosertib, III, Clinical trial, Therapy, Umbralisib, USD, Pfizer, Acquisition, PI3K, Premium, Discovery, News, II, Pharmaceutical industry, Phase

This report provides comprehensive insights about 100+ companies and 100+ pipeline drugs based on PI3K inhibitors pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 100+ companies and 100+ pipeline drugs based on PI3K inhibitors pipeline landscape.
  • This segment of the PI3K inhibitors report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery.
  • This segment of the report provides insights about the different PI3K inhibitors drugs segregated based on following parameters that define the scope of the report.
  • The companies which have their drug candidate based on PI3K inhibitors in the most advanced stage, i.e.

TG Therapeutics Announces Data from the UNITY-CLL Phase 3 Trial Presented at the 63rd American Society of Hematology (ASH) Annual Meeting

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Tuesday, December 14, 2021
Therapy, CRi, FDA, PFS, PT, Company, RMS, CK1, Comorbidity, TG, Population, U2, CR, Immunity, Pneumonitis, Adult, IRC, ALT, Progression-free survival, Degenerative disease, ORR, LinkedIn, Multiple sclerosis, AST, Acquisition, NASDAQ, Survival, Safety, Patient, PI3K, Differentiable function, GLOBE, ASH, Chronic lymphocytic leukemia, Infection, Cell proliferation, CLL, Society, Lymphoid leukemia, Pharmaceutical industry, Health insurance, Engineered wood, Vaccine

Data presentations occurred yesterday evening during the 63rd American Society of Hematology (ASH) annual meeting and exposition.

Key Points: 
  • Data presentations occurred yesterday evening during the 63rd American Society of Hematology (ASH) annual meeting and exposition.
  • CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Monitor for any new or worsening signs and symptoms of infection, including suspected PJP or CMV, during treatment with UKONIQ.

TG Therapeutics Announces Data Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Monday, December 13, 2021
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Data presentations occurred this past weekend during the 63rd American Society of Hematology (ASH) annual meeting and exposition.

Key Points: 
  • Data presentations occurred this past weekend during the 63rd American Society of Hematology (ASH) annual meeting and exposition.
  • Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, We are excited to have showcased four presentations this past weekend, including three oral presentations, during the live ASH annual meeting.
  • 30 patients received umbralisib monotherapy, 66 patients received ublituximab plus umbralisib or U2, and 130 patients received U2 plus bendamustine.
  • At the time of data cut-off, no patients had discontinued treatment due to a treatment-related adverse event across all cohorts.

TG Therapeutics Announces Publication of Results from an Integrated Safety Analysis of UKONIQ® (umbralisib) in Blood Advances

Retrieved on: 
Thursday, September 23, 2021
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Michael S. Weiss, the Companys Chairman and Chief Executive Officer stated, We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances.

Key Points: 
  • Michael S. Weiss, the Companys Chairman and Chief Executive Officer stated, We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances.
  • The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed.
  • These data are described further in the manuscript entitled, Integrated safety analysis of umbralisib, a dual PI3K/CK1 inhibitor, in relapsed/refractory lymphoid malignancies, which was published online in Blood Advances.
  • UKONIQ is a trademark ofTG Therapeutics, Inc.
    UKONIQ is the first and onlyoral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1(CK1) epsilon.

TG Therapeutics Announces Combination Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

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Monday, September 20, 2021
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NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

Key Points: 
  • NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  • Patients with CLL received2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance.
  • The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone.
  • Following the live event, an archive file will be available for replay, for a period of 30 days after the call.

TG Therapeutics Recaps Schedule of Upcoming Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

Retrieved on: 
Monday, September 13, 2021
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NEW YORK, Sept. 13, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of upcoming data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 20, 2021.

Key Points: 
  • NEW YORK, Sept. 13, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of upcoming data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 20, 2021.
  • Full text abstracts are now available through the iwCLL virtual platform, and details of the upcoming data presentations are below.
  • Following the live event, an archive file will be available for replay, for a period of 30 days after the call.
  • The trial enrolled approximately 165 patients with front-line and previously treated CLL at 26 sites throughout the United States.