Ladenburg Thalmann reaffirmed its Buy rating and raised its target price by $2 to $28 on TG Therapeutics Inc TGTX shares following its amendment to its cancer study, GENUINE.
Under GENUINE, TG Therapeutics is studying Ublituximab in combination with Ibrutinib versus Ibrutinib alone in patients with previously treated high-risk Chronic Lymphocytic Leukemia (CLL).
The company lowered enrollment from 200 to 120 in Part 1 of the study with overall response rate (ORR) endpoint, and dropped the 330-patient Part 2 of the study with progression free survival (PFS) endpoint.
“We are encouraged by the amendment to the GENUINE protocol and believe it represents a pragmatic solution to address the slow rate of patient enrollment,” analyst Matthew Kaplan wrote in a note.
Kaplan, who still believes the GENUINE study has a high probability of success, now expects the completion of enrollment in the GENUINE study by the end of 2016 with top-line data in the first half of 2017. The analyst also expects the company to complete a pre-BLA meeting in the fourth quarter of 2017 to support a BLA filing by the first half of 2018.
“We think the probability for the study to meet the ORR primary endpoint is high, given the 95 percent ORR including 1 CR and 18 PRs among 20 high risk R/R CLL patients with 17p/11q deletion and/or p53 mutation, observed in the Phase 2 TG-1101 + Ibrutinib study,” Kaplan highlighted.
Kaplan recommends investors take advantage of the recent pullback the stock, which fell 17 percent on Thursday.
At time of writing, shares of TG Therapeutics rose 4.53 percent to $7.16.
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