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June 12, 2014
09:24 EDTTGTXTG Therapeutics poised to advance next week, says Roth Capital
Roth Capital expects TG Therapeutics' A. Phase II combination data from the TG-1101 / Imbruvica study in B-cell malignancies. expected to be presented this weekend, to be strong. The firm expects the stock to rise at the beginning of next week, and it reiterates a Buy rating on the shares. The firm continues to identify the stock as a Focus Pick.
News For TGTX From The Last 14 Days
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June 19, 2015
09:18 EDTTGTXOn The Fly: Pre-market Movers
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June 18, 2015
11:17 EDTTGTXTG Therapeutics announces Phase 2 clinical trial results of TG-1101
TG Therapeutics announced updated clinical results from its Phase 2 study of TG-1101, the company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, the oral BTK inhibitor. TG-1101 in combination with ibrutinib was well tolerated in the 44 CLL patients evaluable for safety, with day 1 infusion related reactions being the most frequently reported adverse event, the majority of which were Grade 1 or 2 in severity. Only 3 Grade 3 or 4 adverse events were observed in > 5% of patients: neutropenia, anemia, and IRR. Adverse events were manageable with only 7% of CLL patients discontinuing from the study due to an adverse event: 1 diarrhea and 2 non-related adverse events. Overall, aside from day 1 IRR, the addition of TG-1101 to ibrutinib did not appear to alter the safety and tolerability profile of ibrutinib monotherapy. Of the 44 CLL patients treated, 40 were evaluable for response. The 4 patients who were not evaluable included 2 who discontinued due to an adverse event and 2 who withdrew consent, in each case, prior to a first efficacy assessment. Of the 20 CLL patients with previously treated high-risk disease, the patient population we are currently studying in our Phase 3 GENUINE study, 95% achieved an objective response with 20% achieving MRD negativity and/or a CR or an unconfirmed CR (pending bone marrow confirmation) as per the iwCLL. Additionally, disease response improved for the high-risk CLL patients from a median 64% nodal reduction by month 3 to a median 85% nodal reduction by month 6. Amongst all 40 CLL patients evaluable for efficacy, 88% (35/40) achieved an objective response per the iwCLL criteria and 4 patients, or an additional 10%, achieved nodal reductions ranging from 20%-55%, without disease progression.

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