Roth Capital Keeps Bullish Stance On TG Therapeutics Following SPA Agreement With FDA

In a research report issued today, Roth Capital analyst Joseph Pantginis maintained a Buy rating on TG Therapeutics (NASDAQ:TGTX) with a price target of $25, following the the granting of a Special Protocol Assessment (SPA) from the FDA for a planned Phase III study combining TG-1101 and Pharmacyclics’ (NASDAQ:PCYC) Imbruvica for accelerated approval.

Pantginis observed, “TG has embarked on an important and expected path as the Phase III program for TG-1101 and TGR-1202 starts to take shape. If TG-1101 is approved in combination with Imbruvica for CLL patients, we believe it will gain significant market penetration on the anticipated Accelerated Approval. Imbruvica alone in CLL patients has led to significant improvements in PFS and OS (median not met). We believe adding TG-1101 to the mix will only improve upon this. If full approval were to be attained, we believe it will be many years following Accelerated Approval and that during this time, the physician community will have gained significant experience with the combo therapy and its anticipated significant efficacy. Recall that in June 2014 we received the first look at the Phase II combination data showing an 86% response rate in CLL patients (EHA data below). Subsequently in July 2014, the company updated the study, as patient treatment data matured, showing a 100% response rate in CLL patients (7 of 7). The Phase II continued to enroll patients and is now closed. Safety and efficacy from >30 patients will be presented at ASH in December 2014, which we believe will strongly support moving into today’s announced Phase III study.”

According to, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Joseph Pantginis has a total average return of -6.5% and a 43.1% success rate. Pantginis has a 11.5% average return when recommending TGTX, and is ranked #3236 out of 3274 analysts.

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