Sep. 17, 2015, 12:41 PM
Sep. 17, 2015, 9:15 AM
Sep. 17, 2015, 8:42 AM
- TG Therapeutics (NASDAQ:TGTX) and the FDA reach agreement of the design of a Phase 3 clinical trial (Special Protocol Assessment or SPA) of the combination of its glycoengineered anti-CD20 monoclonal antibody, ublituximab (TG-1101) and its once-daily PI3K-delta inhibitor, TGR-1202, for the treatment of chronic lymphocytic leukemia (CLL). The SPA means that the study design adequately addresses the objectives that will support an NDA filing.
- The Phase 3 study, called UNITY-CLL, will be designed to demonstrate the superiority of the combo regimen as measured by its effect on progression-free survival (PFS) over standard-of-care treatment. About 450 patients will be enrolled. The study will commence as soon as feasible.
- Shares are up 15% premarket on light volume.
Jun. 1, 2015, 9:21 AM
Mar. 5, 2015, 9:15 AM
Mar. 4, 2015, 9:50 AM
- Thinly-traded micro cap Coronado Biosciences (CNDO +15.8%) jumps in early trading in response to its announcement of the signing of a collaboration agreement with a researcher at the Dana-Farber Cancer Institute to develop novel immuno-oncology antibodies for blood cancers.
- The company will form a new subsidiary, Checkpoint Therapeutics, to develop a portfolio of antibodies produced in the laboratory of Dr. Wayne Marasco, M.D. at Dana-Farber, including PD-L1, GITR and CAIX. Clinical trials are expected to commence in H2 2016.
- Dr. Marasco will chair the Scientific Advisory Board of the company and Checkpoint will pay Dana-Farber an undisclosed upfront licensing fee, development and sales milestones and royalties on net sales.
- In connection with the Dana-Farber partnership, Checkpoint inks a collaboration deal with TG Therapeutics (TGTX +2.3%) to develop and commercialize anti-PD-L1 and anti-GITR in hematologic malignancies. Both programs are in preclinical development. Checkpoint retains the rights to develop and commercialize both antibodies in solid tumors. Under the terms of the agreement, TG will pay Checkpoint an disclosed upfront license fee, development and sales milestones and tiered single-digit royalties on net sales.
Dec. 11, 2014, 2:09 PM
- TG Therapeutics (TGTX +17.6%) breaks out on a 4x surge in volume. Shares are up over 30% since Tuesday's ASH presentation of clinical trial results for the company's cancer combo.
- In a Phase 1/2 dose escalating study, patients with relapsed/refractory B-cell malignancies were treated with TG-1101 (ublituximab) in combination with the PI3K delta inhibitor, TGR-1202. Nine evaluable patients with chronic lymphocytic leukemia exhibited nodal reductions. Six achieved partial responses and three achieved nodal reductions from 15% to 45%. In 17 evaluable patients with Hodgkin's lymphoma/Richter's syndrome, 83% responded to treatment.
- All patients had been heavily pre-treated with one to three prior lines of therapy so the results are encouraging.
Dec. 11, 2014, 12:45 PM
Sep. 17, 2014, 12:45 PM
Jul. 22, 2014, 12:47 PM
Jun. 13, 2014, 9:11 AM
Jun. 12, 2014, 5:23 PM
- Shares of nano cap TG Therapeutics (TGTX +20.8%) break out today on a seven-fold increase in volume as it continues its post-ASCO up move. At the American Society of Clinical Oncology meeting several weeks ago, the company presented data on its two lead products. The data are encouraging albeit in Phase 1 trials on a small number of subjects.
- In a 35-patient Phase 1 single agent study of TG-1101 (ublituximab) in lymphoma, 100% of chronic lymphocytic leukemia (CLL) patients achieved a peripheral response (6/6) and 67% (4/6) achieved a partial response. 22% (4/18) of Indolent non-Hodgkin Lymphoma patients (iNHL) achieved a complete or partial response.
- In a Phase 1 trial of its PI3K delta inhibitor TGR-1202, 100% (9/9) of evaluable CLL patients dosed at e 800 mg showed significant nodal reductions and 78% (7/9) achieved a partial response or a nodal partial response with lymphocytosis.
- TGTX debuted on the NASDAQ on May 30, 2013 closing at $6.25 on Day 1.
- 73 mutual funds have positions in the stock, up from 51 a year earlier.
Jun. 12, 2014, 12:45 PM
Nov. 25, 2013, 2:11 PM
- TG Therapeutics (TGTX +10.4%) jumps after announcing the initiation of a Phase 1 trial to test the efficacy and safety of a TG-1101/ TGR-1202 combo in relapsed and/or refractory CLL and NHL.
- In other company news, TGTX opens the first expansion cohort in a TGR-1202 dose escalation study — no MTD has yet been determined. (PR)
Oct. 28, 2013, 2:15 PM
- For those looking for the catalyst behind the double-digit decline in shares of TG Therapeutics (TGTX -14.5%), don't ask the company.
- "While [we] do not typically comment on unusual market activity [we are] not aware of any developments that would merit such trading activity," TGTX says, before reiterating that the next milestones are the initiation of combo trials for TG-1101 and BTK and/or PI3K delta inhibitors, and the presentation of Phase 1 data for TGR-1202. (PR)
Sep. 6, 2013, 3:26 PM
TG Therapeutics, Inc. is an innovative, clinical-stage biopharmaceutical company. It is focused on the acquisition, development and commercialization of novel treatments for b-cell malignancies and autoimmune diseases. The company develops two therapies targeting hematological malignancies:... More
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