Study met its primary endpoint, with TG-1101 (ublituximab) plus ibrutinib increasing Overall Response Rate (ORR) by >70% over ibrutinib alone

The combination was well tolerated with a safety profile consistent with the Phase 2 study of ublituximab plus ibrutinib recently published in the British Journal of Haematology

Targeting full data presentation at a medical meeting in 1H17 and meeting with FDA in 2H17 to discuss the results and filing for accelerated approval

Conference call to be held today, Monday March 6, 2017 at 8:30 am ET, with Dr. Anthony Mato from the University of Pennsylvania, a lead enroller in the GENUINE trial

 

NEW YORK, March 06, 2017 -- TG Therapeutics (NASDAQ:TGTX) today announced positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).  For the study, high risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.

- Trial 006 demonstrated a statistically significant and clinically meaningful reduction in OFF-time and increase in proportion of patients “ON” by 8:00 am (primary and key secondary endpoints) -

- The trial also showed statistically significant reduction in troublesome dyskinesia and a complete reduction of OFF-time to zero hours in 66% of responders (post hoc sub-groups analyses) -

 

REHOVOT, Israel, March 01, 2017 --  NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders, today announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints. Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm's high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson's disease.

- Potential best-in-class drug candidate targeting the clinically validated P2X3 receptor for chronic cough -

- Potential to help millions of chronic cough patients, including those who do not respond to current therapies -

 

MONTREAL, Feb. 28, 2017 - BELLUS Health (TSX:BLU), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, and The NEOMED Institute (NEOMED), a not-for-profit organization bridging the gap between basic research and the commercialization of new drugs, today announced that BELLUS Health has obtained an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937) for the treatment of chronic cough. BLU-5937 is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor.

Strong Execution Across Clinical Development, Pipeline, Manufacturing and Pre-Commercial Activities in 2016

On Track to Complete Rolling Biologics License Application to the U.S. Food and Drug Administration for Axicabtagene Ciloleucel by End of First Quarter 2017

Potential U.S. Approval and Launch of Axicabtagene Ciloleucel Expected in 2017

Conference Call to Be Held Today at 9:00 AM Eastern Time

 

SANTA MONICA, Calif. --  Kite Pharma, Inc. (Nasdaq:KITE) today provided a corporate update and reported fourth quarter and full-year 2016 financial results for the period ended December 31, 2016.