TG Therapeutics Shares Plunge After FDA Plans AdComm Meet For Blood Cancer Candidate

TG Therapeutics Inc TGTX shares are falling after FDA notified the Company that it plans to host an Oncologic Drugs Advisory Committee (ODAC) meeting for marketing application regarding ublituximab/ Ukoniq (umbralisib) (U2 combo).
U2 Combo application seeks approval for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The FDA's concern resulting in the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.
The FDA has notified potential questions and discussion topics for the ODAC, including the benefit-risk of the U2 combination in the treatment of CLL or SLL and the benefit-risk of Ukoniq in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL).
In addition, the overall safety profile of the U2 regimen is expected to be reviewed.
The date of the ODAC meeting has not yet been determined, although the FDA has stated that it is targeting the ODAC meet in March or April 2022.
Given this timing, TG Therapeutics believes it is unlikely that the FDA will decide on the application by the PDUFA goal date of March 25, 2022.
Also Read: TG Therapeutics Stock Plunged As H.C. Wainwright Cuts Target Price After Disappointing Q2.
Price Action: TGTX shares are down 41.30% at $13.71 during the market session on the last check Tuesday.