- The stock price of TG Therapeutics Inc (NASDAQ: TGTX) increased by over 7% pre-market. This is why it happened.
The stock price of TG Therapeutics Inc (NASDAQ: TGTX) increased by over 7% pre-market. Investors are responding positively to the company announcing that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, which is the company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQ (umbralisib), the company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022. And the FDA also notified the company that it is not currently planning to hold an advisory committee meeting to discuss this application.
The BLA submission is based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of ublituximab plus UKONIQ (U2) compared to obinutuzumab plus chlorambucil in patients with treatment naive and relapsed or refractory CLL. The U.S. FDA previously granted Fast Track designation to the combination of ublituximab and UKONIQ for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.
“We are extremely pleased that the ublituximab BLA has been accepted by the FDA. This is an important milestone for us as it brings us one step closer to our goal of providing a novel combination treatment option to patients with both treatment naive and relapsed or refractory CLL and SLL. We look forward to collaborating with the FDA throughout this review process.”
— Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics
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