October 13, 2016 / 11:32 AM / 9 months ago

BRIEF-TG Therapeutics amends phase 3 clinical trial

1 Min Read

Oct 13 (Reuters) - TG Therapeutics Inc :

* TG Therapeutics Inc. Amends genuine phase 3 clinical trial to accelerate study completion by revising primary endpoint to overall response rate

* TG Therapeutics Inc- enrollment expected to be completed before year end 2016 with top-line data available in first half of 2017

* TG Therapeutics - if results of revised genuine study are positive, plans to file a bla for accelerated approval based on outcome of pre-BLA meeting

* FDA agrees that overall response rate (orr) data from revised genuine study can be used to request pre-BLA meeting

* TG Therapeutics - amendments expected to save co more than $10 million over next 2 years, and allow company to focus its resources on unity-CLL program

* TG Therapeutics Inc- company believes it could file a BLA in first half of 2018

* TG Therapeutics Inc - target enrollment for genuine phase 3 trial has been reduced to approximately 120 randomized patients Source text for Eikon: Further company coverage:

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