TG Therapeutics, Inc. - TGTX STOCK NEWS

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that the FDA has accepted its New Drug Application for umbralisib, a dual inhibitor for marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA granted the MZL indication Breakthrough Therapy Designation and set a PDUFA goal date of February 15, 2021, while the FL indication has a goal date of June 15, 2021. The NDA is based on UNITY-NHL Phase 2b trial data, which showed an overall response rate (ORR) of 40-50% for both MZL and FL cohorts. The acceptance is a significant step towards providing treatment options for patients with B-cell malignancies.

TG Therapeutics (TGTX) announced the publication of preclinical data on umbralisib, its dual PI3K-delta and CK1-epsilon inhibitor, in Blood Advances. CEO Michael S. Weiss highlighted the encouraging safety profile observed in clinical trials, suggesting a differentiated safety mechanism due to umbralisib’s unique immunomodulatory effects. The study revealed that umbralisib maintained Treg function better than other inhibitors, with significant implications for treating CLL. The data supports the ongoing Phase 3 trials for both umbralisib and ublituximab in hematological malignancies.

TG Therapeutics announced that Executive Chairman and CEO Michael S. Weiss will present at the Raymond James 2020 Human Health Innovation Conference on June 18, 2020, at 3:40 PM ET. The conference will be held virtually, and a live webcast of the presentation can be accessed via the Company's website.

TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases. Its key therapies include ublituximab and umbralisib, currently in Phase 3 clinical trials.

TG Therapeutics (NASDAQ: TGTX) presented promising data at the 25th European Hematology Association annual congress. Key highlights include ongoing favorable results for TG-1701, a selective BTK inhibitor in various B-cell malignancies, showing a 92% overall response rate in CLL patients. The combination therapy of umbralisib and ibrutinib also exhibited a 95% response rate for CLL with no delayed toxicities, emphasizing the potential for effective dual-targeted treatment approaches.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in a fireside chat at the Goldman Sachs 41^st Annual Healthcare Conference on June 11, 2020, at 4:40 PM ET. A live webcast will be available on the company's website. TG Therapeutics focuses on developing novel treatments for B-cell malignancies and autoimmune diseases, with therapies such as ublituximab and umbralisib in Phase 3 clinical development. The company is headquartered in New York City.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that its Executive Chairman and CEO, Michael S. Weiss, will participate in a fireside chat at the Jefferies 2020 Healthcare Conference on June 3, 2020, at 10:00 AM ET. This event will be virtual, and a live webcast can be accessed on the Company’s Investors & Media page. TG Therapeutics focuses on developing therapies for B-cell malignancies and autoimmune diseases, including the Phase 3 clinical development of ublituximab and umbralisib.

TG Therapeutics has announced favorable final results from its GENUINE Phase 3 study, which evaluated the impact of adding ublituximab to ibrutinib in patients with high-risk chronic lymphocytic leukemia (CLL). The combination significantly improved progression-free survival (PFS), overall response rate (ORR), and rates of undetectable minimal residual disease (uMRD) compared to ibrutinib alone. Specifically, ORR was 93% for the combination versus 78% for monotherapy. This study suggests a promising potential for ublituximab combined with ibrutinib in managing high-risk CLL.

On May 15, 2020, TG Therapeutics (NASDAQ: TGTX) announced that preclinical data for TG-1701, a selective BTK inhibitor, will be presented at the 2020 American Association for Cancer Research (AACR) annual meeting. The presentation, titled 'TG-1701, a novel irreversible Bruton’s kinase (BTK) inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro,' will be available on demand starting June 22, 2020. TG Therapeutics is advancing multiple therapies for B-cell malignancies and autoimmune diseases and is currently in various clinical development phases.

TG Therapeutics (NASDAQ: TGTX) announced a $153 million public offering of 8,500,000 shares at $18.00 each, upsized from an initial estimate of 6 million shares. The offering is expected to close on May 19, 2020, pending standard conditions. Proceeds will support the development of ublituximab and umbralisib, possible acquisitions, and general corporate needs. The underwriters have a 30-day option for an additional 1,275,000 shares. Major financial institutions are managing the offering, which utilizes an effective shelf registration filed with the SEC.