TG Therapeutics Pulling Off The Band-Aid To Keep GENUINE Cancer Study On Track

H.C. Wainwright maintains Buy rating on TG Therapeutics Inc TGTX as it welcomes the company’s amendment of a cancer study called GENUINE.

Under GENUINE, TG is studying Ublituximab in combination with Ibrutinib versus Ibrutinib alone in patients with previously treated high-risk Chronic Lymphocytic Leukemia (CLL).

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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.

“Based on the last two quarterly updates, we were mostly aware of the enrollment challenges faced by this study, and we welcome the changes to the protocol that the company elected to put in place,” analyst Andrew Fein wrote in a note.

“In our view, it is interesting to instead take a step back and consider what the former SPA of the 2-part study actually meant: the FDA is willing to accept ORR for accelerated approval (satisfied by Part 1 of GENUINE, still ongoing), and then would also like to see PFS in order to grant full approval,” Fein continued.

However, the analyst acknowledged that the amendments introduce a new element of risk to the GENUINE program and reduced his probability of success assigned to this program to 40 percent from 50 percent.  Fein now projects a U.S. launch for 1101 in 2H19 (previously 2H18), followed by launch in the EU one year later.

As such, the analyst cut his price target to $18 from $22.

At the time of writing, shares of TG Therapeutics rose 3.07 percent to $7.06.

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