TG Therapeutics Inc. (NASDAQ: TGTX) Gets FDA Nod


TG Therapeutics Inc (NASDAQ: TGTX)’s drug candidate TGR-1202 has been granted Orphan Drug Designation (ODD) by the FDA. The ODD marks a milestone for TGTX in the development of the candidate as it means that the company will enjoy certain unusual benefits when the drug gets approved for marketing in the U.S.

TG Therapeutics Inc (NASDAQ: TGTX) is developing TGR-1202 as a treatment for chronic lymphocytic leukemia (CLL). The candidate is currently being tested in UNITY-CLL Phase 3 study. The trial is being carried out in patients that have previously been treated for CLL and those who have not received prior treatment for the disease.

Proprietary protection

TGTX’s CEO, Michael S. Weiss, said that the ODD designation adds another level of proprietary protection for TGR-1202. On top of that, he said that the designation could provide them with certain financial and regulatory benefits that could go a long way into increasing the gains that the company makes from the drug once it comes to market.

Making the difference

Though TGR-1202 is a PI3k delta inhibitor, CEO Weiss noted that it is a differentiated kind of PI3k delta inhibitor and the ongoing Phase 3 will prove that.

What comes with ODD?

Not every drug candidate qualifies for ODD, which is why TG Therapeutics Inc. (NASDAQ: TGTX) is excited that the FDA has recognized its TGR-1202 as an orphan drug. The FDA grants ODD to drugs that target to a treat a rare disease that affects no more than 200,000 people in the U.S.

Drug candidates that carry ODD may enjoy tax credits on the cost of the clinical trials and other fee waivers. If candidate with ODD label makes it to market, it becomes entitled to orphan drug exclusivity.

It is estimated that about 20,000 new cases of CLL are discovered in the U.S. every year. CLL is characterized by too much production of a type of white blood cell and it is a common type of leukemia that afflicts adults in the middle age or just after they have passed the middle age.

Does TGTX have the cash to chase TGR-1202 dream?

There are still a number of tests that are remaining TGR-1202. That raises the question of whether TG Therapeutics Inc. (NASDAQ: TGTX) has enough financial resources to chase the TGR-1202 dream. As for cash issue, the management of TGTX doesn’t appear worried about the company’s liquidity. TGTX finished 2Q2016 with cash and equivalents of $75.8 million, which the management said should be adequate to finance operations until 2Q2018.


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