TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company focused on the acquisition, development, and commercialization of treatments for B-cell malignancies and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for ublituximab, to treat patients affected with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
Shares of TG Therapeutics Inc. (TGTX) were up 3.80% at $35.00 as of this writing. TGTX stock closed last session at $33.72, increasing 1.57% or $0.52. Shares of TGTX fluctuated between $33.00 and $34.19 throughout the day. The price range of the company’s shares was between $33.00 and $34.19. It traded 1.07 million shares, which was below its daily average of 1.49 million shares over 100 days.
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About FDA approval
The FDA has set a Prescription Drug User Fee Act (PDUFA) objective date of March 25, 2022. The FDA also confirmed TG Therapeutics, Inc. that it is not presently planning to hold an advisory committee meeting talk over this application.
The BLA submission was in accordance to the UNITY-CLL trial, an international Phase 3 trial assessing the combination of ublituximab plus UKONIQ (U2) in comparison to obinutuzumab plus chlorambucil in patients with treatment-naive and history of relapsed or refractory CLL. The U.S. FDA priorly granted Fast Track designation to the combination of ublituximab and UKONIQ to treat adult patients with CLL and orphan drug designation for ublituximab combined with UKONIQ for the treatment of CLL.
Fast Track Program
Fast Track is a program developed to expedite the review of drugs that treat serious disorders and that depict the potential to fulfill an unmet medical need. Addressing an unmet medical need is described as the provision of therapy where no alternative exists or provision of therapy that may be potentially more effective and consist of higher efficacy.
A drug that is granted Fast Track designation is allowed more frequent interactions with the FDA, has a higher priority review if relevant conditions are met, and rolling submission of the BLA or New Drug Application.
ORPHAN DRUG DESIGNATION
Orphan drug designation is received from the FDA to drugs and biologics which are safe and have high tolerability and specialize in diagnosis or prevention of rare diseases/disorders that affect lesser than 200,000 people in the U.S.
Orphan drug designation provides certain incentives which may be inclusive of tax credits towards the expense of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation is granted the first FDA approval for the disorder for which it has such designation, the product is given the orphan product exclusivity.
Positive topline data in clinical trials combined with FDA compliance and Orphan drug designation has increased shareholder expectation, with TGTX stock price increasing substantially.