TG rises on SPA for combination CLL therapy

TG Therapeutics Inc. (NASDAQ:TGTX) rose $2.65 (23%) to $14.37 after the company said it received an SPA from FDA for the Phase III UNITY-CLL trial of ublituximab ( TG-1101) in combination with TGR-1202 to treat chronic lymphocytic leukemia (CLL). Chairman, President and CEO Michael Weiss said the trial is slated to begin within the next two months.

The company plans to use progression free survival (PFS) data to support full approval of a BLA for the combination therapy. TG said it may use data from an interim analysis conducted after full enrollment to request accelerated approval of ublituximab plus TGR-1202, though Weiss declined to disclose the endpoint for the analysis. ...