TG Therapeutics, Inc. (NASDAQ: TGTX) has announced Wednesday that it has received the Fast Track Designation for its ublituximab/umbralisib combo for the treatment of adult patients with chronic lymphocytic leukemia (CLL) from the FDA.
Fast Track is basically the program developed to speed up the review of drugs that treat serious diseases and address unmet medical needs. Filling an unmet medical need is to provide the treatment for those diseases for which no medical treatment is available earlier or offering a medical treatment that may be better than available therapy.
TG Therapeutics, Inc. (NASDAQ: TGTX) shares were trading up 0.31% at $28.75 at the time of writing on Wednesday. TG Therapeutics, Inc. share price went from a low point around $5.38 to briefly over $31.97 in the past 52 weeks, though shares have since pulled back to $28.75. TGTX market cap has remained high, hitting $334.37M at the time of writing.
The application of Fast Track designation is based on the data from UNITY-CLL Phase 3 study. The company has announced earlier in UNITY-CLL Phase 3 data that the treatment has shown a positive result. This Fast Track Designation is very important for the company. UNITY-CLL Phase 3 is the study to analyze the combination of ublituximab and umbralisib. Ublituximab is a glycoengineered anti-CD20 monoclonal antibody, and umbralisib is a dual inhibitor of PI3K-delta and CK1-epsilon.
Chronic lymphocytic leukemia (CLL) is a serious issue in the current period as more than 20,000 new cases have been reported alone in the US. After initial treatment, its symptoms disappear for a period of time but the disease is considered incurable. People need additional treatment after the return of the malignant cells.