TG Therapeutics Inc (NASDAQ:TGTX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for TG-1101 (ublituximab) the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, for the treatment of patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). There are currently noFDA approved treatments for NMO or NMOSD.
“We are pleased to announce our first orphan drug designation for TG-1101 in a non-oncology indication, providing additional proprietary protection for TG-1101, which has a composition of matter patent in the U.S. through mid-2029, exclusive of patent term extensions. As demonstrated with the announcement earlier this week of the orphan drug designation for TGR-1202 in the treatment of CLL, we are committed to building strong proprietary protection around our key compounds, which includes a multi-level patent strategy and orphan drug designations where appropriate,” stated Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. “NMO is closely related to Multiple Sclerosis, an area of significant interest to us. We look forward to presenting early data from our current Phase 1b study of TG-1101 in NMO at the ECTRIMS (European Committee for the Treatment and Research in Multiple Sclerosis) conference this September, which we believe will provide an early peek into the effects of TG-1101 in patients with autoimmune diseases.”
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
Neuromyelitis optica (NMO) and NMO Spectrum Disorder (NMOSD), also known as Devic’s disease, is an immune-mediated severe chronic inflammatory disorder with involvement of different regions of the central nervous system (CNS) that primarily affects the optic nerve and the spinal cord. The damage to the optic nerves produces swelling and inflammation that cause pain and loss of vision, while damage to the spinal cord causes weakness or paralysis in the legs or arms, loss of sensation, and problems with bladder and bowel function. NMO is a relapsing-remitting form of autoimmune disease, similar to MS. During a relapse, new damage to the optic nerves and/or spinal cord can lead to accumulating disability. However, unlike MS, progressive phase of this disease is very rare. Therefore, preventing attacks is critical to a good long-term outcome. There is currently no cure or approved medicine for NMO, which affects about five in 100,000 people. (Original Source)
Shares of TG Therapeutics are up nearly 5% to $6.56 in pre-market trading Friday. 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 $5.94 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 24, FBR analyst Edward White reiterated a Buy rating on TGTX. Separately, on August 9, 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, Edward White and Jonathan Aschoff have a total average return of 1.8% and -10.1% respectively. White has a success rate of 47% and is ranked #1518 out of 4127 analysts, while Aschoff has a success rate of 37% 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. TG Therapeutics was founded by Michael S. Weiss on May 18, 1993 and is headquartered in New York, NY.