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TG Therapeutics (TGTX) Plans Conf. Call for GENUINE Phase 3 Update

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TG Therapeutics (TGTX) Shares Move Up from Lows Amid Amended GENUINE Phase 3 Protocol

October 13, 2016 7:24 AM EDT

TG Therapeutics (Nasdaq: TGTX) shares are seeing a slight rebound Thursday morning after the company announced an amended protocol for its GENUINE Phase 3 trial. The stock is down around 4 percent, but was 22 percent lower Wednesday night.

For more on the updated protocol, click here.

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TG Therapeutics (TGTX) Files Amended Protocol for GENUINE Phase 3 Trial; Revises Primary Endpoint

October 13, 2016 7:02 AM EDT

TG Therapeutics, Inc. (Nasdaq : TGTX) announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial. Prior to the amendments, the GENUINE study consisted of two parts:

Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; andPart II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival (PFS) in all study patients (approximately 330), to... More