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Biotech / Medical : biotech fireworks

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From: Julius Wong	3/6/2017 8:15:23 AM
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TG Therapeutics's blood cancer candidate ublituximab successful in late-state study; shares jump 53% premarket TG Therapeutics (NASDAQ: TGTX) is up 53% premarket on robust volume in response to its announcement of positive results from a Phase 3 clinical trial, GENUINE, assessing TG-1101 (ublituximab) plus ibrutinib [AbbVie's (NYSE: ABBV) Imbruvica] in treatment-experienced high-risk chronic lymphocytic leukemia (CLL) patients. The study met its primary endpoint of overall response rate (ORR) compared to ibrutinib alone in both the intent-to-treat population (p=0.001) and treated population (p<0.001). Specifically, in the treated population, the ORR was 80% for TG-1101 plus ibrutinib versus 47% for ibrutinib alone. A complete analysis of the data will be submitted for presentation at an upcoming medical conference. The company plans to meet with the FDA as soon as possible afterward to discuss an application for accelerated approval. TG-1101 is a glycoengineered anti-CD20 monoclonal antibody.

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