TG Therapeutics Inc (NASDAQ:TGTX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL).
The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL as well as the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
“Receiving orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 provides another layer of exclusivity protection on top of the composition of matter patents which were issued for TG-1101 and TGR-1202 last year and patents on the combination that have been filed and are pending approval,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. “Additionally, with enrollment into our UNITY-CLL Phase 3 trial currently exceeding our expectations, we expect to be able to commence a regulatory filing for the combination in 2018 and having orphan drug designation will provide certain cost saving advantages for us during the regulatory approval process.” (Original Source)
Shares of TG Therapeutics closed last Friday at $4.95, down $0.05 or -1.00%. TGTX has a 1-year high of $10.50 and a 1-year low of $4.25. The stock’s 50-day moving average is $5.16 and its 200-day moving average is $6.11.
On the ratings front, TG Therapeutics has been the subject of a number of recent research reports. In a report issued on January 5, FBR analyst Edward White maintained a Buy rating on TGTX, with a price target of $24, which represents a potential upside of 385% from where the stock is currently trading. Separately, on December 7, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $33.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward White and Joseph Pantginis have a yearly average loss of -12.8% and -17.2% respectively. White has a success rate of 24% and is ranked #4255 out of 4350 analysts, while Pantginis has a success rate of 31% and is ranked #4285.
TG Therapeutics, Inc. is a biopharmaceutical company. It is focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The company develops two therapies targeting hematological malignancies: TG-1101 and TGR-1202.