The pharmaceuticals sector in the US is currently on pins and needles as it anxiously awaits an action plan from the new Trump government.
While the sector anticipates to benefit from expected deregulation, it is also apprehensive about the likely caps on drug price increases.
However, for companies working in niche areas that are developing treatments for more rare diseases are expected to keep up their performance. TG Therapeutics (NASDAQ:TGTX) is one such company which is currently working on two lead drug candidates.
The company received a big boost yesterday morning as its combination of TG-1101 and TGR-1202 received orphan drug designation from the FDA. The combination is being tested for treating patients with diffuse large B-cell lymphoma (DLBCL).
The company said that DLBCL is a major area which has unmet medical requirements with any breakthrough in the field likely to be highly lucrative for the company.
This combination already has orphan drug status for the treatment of chronic lymphocytic leukemia. It is estimated that there are approximately 20,000 new cases of chronic lymphocytic leukemia diagnosed each year in the United States.
Orphan drug designation is a highly sought after status for the pharma companies as the FDA grants the title to only those 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.
It leads to various incentives such as tax credits towards the cost of clinical trials and prescription drug user fee waivers.
Orphan product exclusivity would be another Company benefit.
Orphan product exclusivity occurs when a product receives the first FDA approval for the disease for which it has such designation, giving the drug exclusivity. These features are expected to provide a boost to TG Therapeutics’ fortunes.
The company is working on other drug candidates as well. TG Therapeutics recently announced the completion of enrollment into Part 1 of its ongoing Phase 2 study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.
Both TG-1101 and TGR-1202 are major product candidates for the company. With various ongoing clinical trials for both the products, the company has strong future prospects.
With that said, shares of TGTX had a somewhat disappointing performance in the past 12 months, with shares down 53% during that time. While it was a rough year, the selloff was sector wide so the negative sentiment should be viewed with a grain of salt. However, with the encouraging news coming its way, the company’s stock could see a revival in the near future.
