TG Therapeutics Inc (NASDAQ:TGTX) shares crashed almost 17% yesterday on back of the biotech firm’s announcement that it has filed with the FDA an amended protocol for the GENIUNE Phase 3 study evaluating its pipeline drug TG-1101 (ublituximab), designed to treat patients with hematologic malignancies as well as patients suffering from autoimmune disorders.
The GENUINE trial is evaluating TG-1101 in combination with AbbVie’s drug Imbruvica in previously treated Chronic Lymphocytic Leukemia (CLL) patients with high-risk cytogenetic features.
Despite the reorganization that now eliminates Part II of a formerly two-part study, H.C. Wainwright Andrew Fein remains bullish on the firm, indicating these changes are “necessary, timely, and generally should not have been a surprise,” especially when considering the past two quarterly updates that revealed the hurdles the trial confronted with enrollment.
Therefore, Fein welcomes the protocol modifications and reiterates a Buy rating on shares of TGTX. However, taking into account his own thought processes on a development timetable as well as GENUINE’s odds to succeed, Fein conservatively reduces the price target from $22 to $18, which represents a nearly 159% increase from where the stock is currently trading.
The analyst asserts, “We recognize that although a new strategy and all the necessary parts are there, the changes to the powering assumptions and the bifurcation of the data package (ORR and PFS readouts now coming from two different studies in slightly different populations) introduce a new element of risk to the GENUINE program.”
“We highlight that eliminating the GENUINE program from our valuation completely would lead to a $16 PT. Then, in the larger picture, we believe that this quick and timely reorganization of the GENUINE study was the right step forward, keeping an already-invested effort still in play while focusing the attention of clinical sites and biotech investors towards the value-driving UNITY study,” Fein concludes.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, five-star analyst Andrew Fein is ranked #155 out of 4,182 analysts. Fein has a 52% success rate and yields 16.2% in his annual returns. However, when recommending TGTX, Fein loses 10.2% in average profits on the stock.
TipRanks analytics exhibit TGTX as a Strong Buy. Based on 4 analysts polled in the last 3 months, 100% rate a Buy on TGTX. The 12-month average price target stands at $30.50, marking a 345% upside from where the shares last closed.