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TG Therapeutics Inc (TGTX.OQ)

TGTX.OQ on NASDAQ Stock Exchange Capital Market

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14 Dec 2017
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Latest Key Developments (Source: Significant Developments)

TG Therapeutics Announces Initiation Of Randomized Phase II Trial In Follicular Lymphoma
Monday, 27 Nov 2017 07:30am EST 

Nov 27 (Reuters) - TG Therapeutics Inc ::TG THERAPEUTICS ANNOUNCES INITIATION OF NATIONAL CANCER INSTITUTE/SWOG-SPONSORED RANDOMIZED PHASE II TRIAL IN FOLLICULAR LYMPHOMA.  Full Article

TG Therapeutics qtrly net loss per common share $0.48
Wednesday, 8 Nov 2017 07:30am EST 

Nov 8 (Reuters) - TG Therapeutics Inc ::TG therapeutics, inc. Provides business update and reports third quarter 2017 financial results.TG therapeutics inc - qtrly net loss per common share $0.48.Q3 earnings per share view $-0.43 -- Thomson Reuters I/B/E/S.TG therapeutics inc - believes cash and cash equivalents will be sufficient to fund planned operations through 2018​.  Full Article

TG Therapeutics announces completion of full enrollment in UNITY-CLL phase 3 trial
Monday, 16 Oct 2017 07:30am EDT 

Oct 16 (Reuters) - TG Therapeutics Inc : :TG Therapeutics announces completion of full enrollment in the UNITY-CLL phase 3 trial.TG Therapeutics Inc - ‍targeting an NDA/BLA filing for combination of TGR-1202 + TG-1101 in 2H18​.TG Therapeutics Inc - ‍top-line ORR data from UNITY-CLL trial expected in 2Q18​.  Full Article

TG Therapeutics ‍says FDA confirms accelerated approval for TG-1101 based on overall response rate a review issue
Monday, 16 Oct 2017 07:30am EDT 

Oct 16 (Reuters) - TG Therapeutics Inc : :TG Therapeutics provides update on fda meeting for genuine phase 3 trial.TG Therapeutics - co ‍has met with U.S. FDA regarding use of results from genuine phase 3 trial to support bla filing for approval of TG-1101​.TG Therapeutics Inc - ‍fda confirmed that accelerated approval for TG-1101 based on overall response rate would be a review issue ​.TG Therapeutics - ‍FDA asked co to consider future available therapy in risk/benefit analysis in future BLA filing that may impact accelerated approval.TG Therapeutics - co, FDA also discussed potential use of progression free survival results from genuine trial to support full approval of TG-1101​.TG Therapeutics Inc - ‍plans to have a follow-up meeting with FDA to discuss use of PFs endpoint in more detail before end of year​.  Full Article

TG Therapeutics says phase 3 ULTIMATE trials evaluating TG-1101 in multiple sclerosis patients are now open for enrollment
Friday, 15 Sep 2017 07:30am EDT 

Sept 15 (Reuters) - TG Therapeutics Inc :TG Therapeutics Inc announces the phase 3 ultimate trials evaluating tg-1101 in patients with multiple sclerosis are now open for enrollment.TG Therapeutics Inc - ‍ ULTIMATE I and ULTIMATE II phase 3 trials will each enroll approximately 440 subjects, randomized in a 1:1 ratio.  Full Article

TG Therapeutics announces completion of target enrollment
Tuesday, 5 Sep 2017 07:30am EDT 

Sept 5 (Reuters) - TG Therapeutics Inc ::TG Therapeutics announces completion of target enrollment in the unity-CLL phase 3 trial.TG Therapeutics Inc - ‍unity-CLL phase 3 trial is being conducted pursuant to a special protocol assessment (SPA) agreement with FDA.TG Therapeutics Inc - ‍enrollment is expected to continue until mid-October​.TG Therapeutics Inc- expect to deliver top-line data on ORR endpoint earlier than anticipated, now expected in Q2 of 2018.  Full Article

TG Therapeutics announces successful outcome from first pre-planned interim analysis
Thursday, 10 Aug 2017 07:30am EDT 

Aug 10 (Reuters) - TG Therapeutics Inc :TG Therapeutics Inc announces successful outcome from the first pre-planned interim analysis by independent DSMB of the DLBCL cohort in the unity-NHL PHASE 2B trial.TG Therapeutics Inc - ‍DSMB recommends continued enrollment in TGR-1202 + TG-1101 arm and no further enrollment into single agent TGR-1202 arm​.TG Therapeutics Inc - ‍single agent TGR-1202 arm will be replaced with triple combination of TG-1101, TGR-1202 and bendamustine​.  Full Article

TG Therapeutics Q2 loss per share ‍$0.45​
Wednesday, 9 Aug 2017 07:30am EDT 

Aug 9 (Reuters) - Tg Therapeutics Inc :Tg therapeutics Inc provides business update and reports second quarter 2017 financial results.Qtrly loss per share ‍$0.45​.Expect G&A expenses to remain relatively constant through remainder of 2017​.  Full Article

TG therapeutics provides FDA update on multiple sclerosis study
Tuesday, 1 Aug 2017 07:30am EDT 

Aug 1 (Reuters) - Tg Therapeutics Inc :Announces special protocol assessment (spa) agreement with the FDA for a Phase 3 program of TG-1101 (ublituximab) for patients with multiple sclerosis (MS).Global Phase 3 program expected to commence before end of Q3 2017.RMS phase 3 program consists of two trials, called Ultimate I and Ultimate II trials.  Full Article

TG Therapeutics gives follow-up data from chemo-free triple combination
Monday, 5 Jun 2017 09:00am EDT 

June 5 (Reuters) - TG Therapeutics Inc :TG Therapeutics Inc Announces follow-up data from the chemo-free triple combination of TG-1101, TGR-1202, and Ibrutinib at the 53rd annual meeting of the American Society Of Clinical Oncology.TG Therapeutics Inc - ‍ triple combination appeared to be well tolerated in all patients, with neutropenia and pneumonia​‍​.  Full Article

BRIEF-TG Therapeutics qtrly net loss per common share $0.48

* TG therapeutics, inc. Provides business update and reports third quarter 2017 financial results