TG Therapeutics, Inc. (NASDAQ:TGTX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s oral, next generation PI3K Delta inhibitor, TGR-1202, for the treatment of patients with chronic lymphocytic leukemia (CLL). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL.
“We are pleased to receive orphan drug designation for TGR-1202. In addition to our composition of matter patent for TGR-1202 which issued earlier this year, the granting of this orphan drug designation offers an additional level of proprietary protection and also may provide us certain other regulatory and financial benefits,” said Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. “We continue to be excited about the differentiated safety profile of TGR-1202 over other PI3k delta inhibitors and believe the UNITY-CLL Phase 3 Trial will showcase those differences.”
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States. (Original Source)
Shares of TG Therapeutics are currently trading at $6.62, up $0.40 or 6.43%. TGTX has a 1-year high of $15.06 and a 1-year low of $5.41. The stock’s 50-day moving average is $5.95 and its 200-day moving average is $7.71.
On the ratings front, TGTX has been the subject of a number of recent research reports. In a report issued on August 9, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on TGTX. Separately, on the same day, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $28.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Jonathan Aschoff have a total average return of 16.1% and -10.1% respectively. Fein has a success rate of 50.7% and is ranked #145 out of 4123 analysts, while Aschoff has a success rate of 37.1% and is ranked #4003.
Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $33.00 which is 430.5% above where the stock closed yesterday.
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.