Ublituximab

Breaking Into a Saturated Relapsing Remitting Multiple Sclerosis Market: Where Should Developers Focus?

Retrieved on: 
Tuesday, August 1, 2023
DMT, Marketing, Disability, Launch, Neurology, Multiple sclerosis, EMD, BTK, TG, MS, DMTS, Hook effect, RMS, HIV disease progression rates, Patient, PPMS, SPMS, Therapy, RealTime, Safety, Pharmaceutical industry, Genentech, Novartis, Ublituximab, Ocrelizumab

The most recent report (n=102 US based neurologists) shows that what motivates neurologists’ prescribing is efficacy in both minimizing relapses and delaying disability progression.

Key Points: 
  • The most recent report (n=102 US based neurologists) shows that what motivates neurologists’ prescribing is efficacy in both minimizing relapses and delaying disability progression.
  • Other drivers of brand choice from the past, such as patient support services, do not appear to be major considerations of first therapy choice today.
  • Beyond understanding evolving treatment patterns and challenges, the RealTime Dynamix™ study also evaluated neurologists’ expectations for products in development.
  • Breaking into the RMS market will certainly not be easy, so deep market insights will be key along with outstanding clinical data.

Early Launch Metrics for TG Therapeutics' Briumvi in RMS Trail Those of Novartis' In-Class Competitor Kesimpta, According to Spherix Global Insights

Retrieved on: 
Wednesday, March 15, 2023
Acquisition, Multiple sclerosis, Therapy, RMS, MS, TG, Patient, CD20, Neurology, DMT, WAC, Pharmaceutical industry, Ublituximab, Novartis, Genentech

EXTON, Pa., March 15, 2023 /PRNewswire/ -- With the U.S. commercial launch of TG Therapeutics' Briumvi (ublituximab-xiiy) on January 26th, 2023 for the treatment of relapsing multiple sclerosis (RMS), patients gained access to the third therapy in the increasingly dominant anti-CD20 drug class. Briumvi joins established blockbusters Ocrevus (ocrelizumab) from Genentech and Kesimpta (ofatumumab) from Novartis in this class.

Key Points: 
  • Briumvi joins established blockbusters Ocrevus (ocrelizumab) from Genentech and Kesimpta (ofatumumab) from Novartis in this class.
  • With Briumvi's later entrance onto the MS market, TG Therapeutics is positioning its brand for success by highlighting its distinct properties, particularly compared with Ocrevus.
  • However, when compared with Novartis' subcutaneous anti-CD20 brand, fewer neurologists considered Briumvi to be a substantial advance over other MS agents.
  • Even with early launch metrics being overshadowed by those for Kesimpta, half of respondents anticipate Briumvi trial for RMS in six months' time.

First Patient in Minnesota Receives TG Therapeutics' New Multiple Sclerosis Drug at Infusion Associates Outpatient Infusion Center

Retrieved on: 
Wednesday, March 8, 2023
Fatigue, Multiple sclerosis, Insurance, Brain, Patient, MS, RMS, Person, Hypoesthesia, Medicine, Central nervous system, Therapy, Quality of life, Disability, Weakness, Minnesota Center for Book Arts, FDA, Conditional sentence, TG, Medical device, Pharmaceutical industry, Ublituximab

PLYMOUTH, Minn., March 8, 2023 /PRNewswire/ -- Infusion Associates (IA), one of the Midwest's leading providers of medically prescribed outpatient infusion and injection therapies, completed their first Briumvi™ (ublituximab-xiiy) infusion treatment for a patient at their Plymouth, Minnesota location.

Key Points: 
  • PLYMOUTH, Minn., March 8, 2023 /PRNewswire/ -- Infusion Associates (IA), one of the Midwest's leading providers of medically prescribed outpatient infusion and injection therapies, completed their first Briumvi™ (ublituximab-xiiy) infusion treatment for a patient at their Plymouth, Minnesota location.
  • Infusion Associates is the first healthcare facility in Minnesota to administer the new FDA approved drug treating multiple sclerosis (MS).
  • Multiple sclerosis is a chronic disease that impacts the central nervous system, disrupting the flow of information within the brain and between the brain and body.
  • Infusion Associates' leading clinical team has been caring for patients with chronic illnesses, including multiple sclerosis, through infusion and injection treatments for over 20 years.

Declining MS Sales for Historic Powerhouse Biogen Point to Shifting Tides in the Multiple Sclerosis Market According to Spherix Global Insights

Retrieved on: 
Friday, February 17, 2023
Launch, NASA RealWorld-InWorld Engineering Design Challenge, Neurology, DMTS, Patient, TG, Merck Serono, Therapy, RealTime, Siponimod, Sanofi, FDA, Multiple sclerosis, BTK, MS, Fine chemical, Online shopping, Pharmaceutical industry, Genentech, Novartis, Biogen, Ublituximab

EXTON, Pa., Feb. 17, 2023 /PRNewswire/ -- According to Biogen's earnings call on Wednesday, February 15, 2023, sales for its multiple sclerosis (MS) franchise are down for the third year in a row. The company attributed the 2022 decline to generic erosion, pricing pressures, and a shift in prescribing patterns.

Key Points: 
  • The company attributed the 2022 decline to generic erosion, pricing pressures, and a shift in prescribing patterns.
  • As part of its' quarterly market tracking RealTime Dynamix™ service, Spherix Global Insights probed U.S. neurologists on satisfaction with Biogen's and Novartis' MS DMTs, as well as perceptions of both companies' MS portfolios.
  • Additionally, outside of branded DMTs, the MS market could see its first-ever biosimilar, with the expected launch of Sandoz/Polpharma Biologics' biosimilar natalizumab.
  • Since 2016, Spherix Global Insights has tracked the MS market and will continue coverage of this highly dynamic space.

TG Therapeutics Announces FDA Approval of BRIUMVI™ (ublituximab-xiiy)

Retrieved on: 
Wednesday, December 28, 2022
The New England Journal of Medicine, Multiple sclerosis, Advocacy, Central nervous system, FAAN, Food, Therapy, MD, MS, Research, News, Neurology, Ublituximab, CD20, HIV disease progression rates, ARR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TG, Patient, Family, RMS, Pediatrics, Consortium, MSN, Multiple sclerosis research, Stanford University, Physician, FDA, II, CMSC, History, Pharmaceutical industry, NEW YORK

Results from the ULTIMATE I & II trials were recently published in August 2022 in The New England Journal of Medicine.

Key Points: 
  • Results from the ULTIMATE I & II trials were recently published in August 2022 in The New England Journal of Medicine.
  • Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, "Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of BRIUMVI.
  • June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer of the Consortium of Multiple Sclerosis Centers has stated, “The approval of BRIUMVI is wonderful news.
  • Congratulations to TG Therapeutics from the CMSC and our leadership.”

TG Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Investor, Private Securities Litigation Reform Act, Sclerosis, Finance, TG, Food, Risk, Food and Drug Administration Amendments Act of 2007, Ublituximab, Research, SG, European Committee of the Regions, Multiple sclerosis, BLA, COVID-19, Therapy, R, Annual report, NASDAQ, II, Goal, U.S. Securities and Exchange Commission, PDUFA, Company, Biologics license application, D, Clinical trial, Conference, Patient, Treatment, Acquisition, ARR, FDA, Trial of the century, Renewable energy, Pharmaceutical industry, RMS

NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the third quarter ended September 30, 2022 and recent company developments, along with a business outlook for the remainder of 2022.

Key Points: 
  • NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the third quarter ended September 30, 2022 and recent company developments, along with a business outlook for the remainder of 2022.
  • Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $197.7 million as of September 30, 2022.
  • The Company will host a conference call today, November 10, 2022, at 8:30 AM ET, to discuss the Companys third quarter 2022 financial results.
  • In order 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.

TG Therapeutics to Host Conference Call on Third Quarter 2022 Financial Results and Business Update

Retrieved on: 
Tuesday, November 8, 2022
Investor, GLOBE, RMS, TG, Ublituximab, Multiple sclerosis, Therapy, NASDAQ, Company, Conference, Patient, Acquisition, Video game, Pharmaceutical industry

NEW YORK, Nov. 08, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held on Thursday, November 10, 2022 at 8:30 AM ET to discuss results for the third quarter of 2022.

Key Points: 
  • NEW YORK, Nov. 08, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held on Thursday, November 10, 2022 at 8:30 AM ET to discuss results for the third quarter of 2022.
  • Michael S. Weiss, Chairman and Chief Executive Officer, will host the call.
  • In order 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.
  • TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

Final Deadline: Bronstein, Gewirtz & Grossman, LLC Reminds TG Therapeutics, Inc. (TGTX) Investors of Class Action and Last Few Hours to Actively Participate

Retrieved on: 
Friday, September 16, 2022
Legal, Professional Services, Complaint, FDA, LLC, Company, Review, NDA, Therapy, Person, Survival, Lists of schools in England, TG, Court, NASDAQ, Overalls, U2, Medical device, Pharmaceutical industry, Ublituximab, Umbralisib

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies.

Key Points: 
  • The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies.
  • or his Law Clerk and Client Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484.
  • If you suffered a loss in TG Therapeutics, you have until September 16, 2022, to request that the Court appoint you as lead plaintiff.
  • Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits.

TG Therapeutics, Inc. Investors: Last Days to Actively Participate in the Class Action Lawsuit; September 16, 2022 Deadline; Portnoy Law Firm

Retrieved on: 
Thursday, September 15, 2022
Complaint, FDA, Company, Review, NDA, Therapy, Survival, Lists of schools in England, TG, NASDAQ, GLOBE, Overalls, U2, Pharmaceutical industry, Ublituximab, Umbralisib

LOS ANGELES, Sept. 15, 2022 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises TG Therapeutics, Inc. (“TG Therapeutics” or the “Company”) (NASDAQ: TGTX) investors that a class action filed on behalf of investors. TG Therapeutics investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq.        

Key Points: 
  • LOS ANGELES, Sept. 15, 2022 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises TG Therapeutics, Inc. (TG Therapeutics or the Company) (NASDAQ: TGTX) investors that a class action filed on behalf of investors.
  • TG Therapeutics investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in TG Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – TGTX

Retrieved on: 
Thursday, September 15, 2022
Adult, Securities Exchange Act of 1934, Chronic lymphocytic leukemia, Multiple sclerosis, Complaint, Oncology Drug Advisory Committee, Risk, Biologics license application, FDA, Food, Company, Acquisition, Pomerantz, News, Review, Lists of action films, Prescription Drug User Fee Act, NDA, Therapy, Person, Survival, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LLP, Lymphoid leukemia, TG, Lists of schools in England, ODAC, Shanda, SEC Rule 10b-5, CLL, Degenerative disease, New Drug Application, Court, NASDAQ, Lymphocytosis, District court, Ext, Overalls, GLOBE, BLA, SLL, Death, Follicular lymphoma, Medical device, Pharmaceutical industry, High-performance plastics, Ublituximab, Umbralisib, U2

To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.

Key Points: 
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • TG Therapeutics, a commercial stage biopharmaceutical company, focuses on the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.