Roth Affirms TG Therapeutics (TGTX) at 'Focus Pick'; Sees Strong Results in 2016

Roth Capital reaffirms TG Therapeutics (Nasdaq: TGTX) with a Buy (and Focus Pick) rating and $33 price target following the company's FY15 results report, which was made late Monday.

Joseph Pantginis, Ph.D., commented, The GENUINE Phase III (under SPA) is now enrolling at >150 U.S. sites and complete enrollment is expected by year-end and top-line data in early 2017. TG announced that it will be instituting a new screening protocol based on KOL feedback, which should help bolster enrollment for both GENUINE and UNITY-CLL.

To this end, it has been noted that most community sites are not screening for high-risk features in CLL patients, and these patients (~50%) are then lost to GENUINE randomization. At the time of relapse, patients will now be screened at all sites uniformly and patients who are ineligible for GENUINE, could then be enrolled into the UNITY-CLL study with an overall benefit to TG's trial goals. The UNITY-CLL Phase III (under SPA) just enrolled its first patients and there are currently 8 open sites in the U.S, with 50 expected by the end of May and 150 international sites by year end.

The company will also be starting its planned Phase II with '1101 in MS patients, starting the company's foray into autoimmune disorders. Initial B-cell depletion data are expected by year-end and the program could be in Phase III in 2017. The UNITY-DLBCL program will open for enrollment in the next several months as a Phase IIb and will be conducted in two steps similar to GENUINE, Pantginis said.

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