TG Therapeutics Shares Plunge After FDA Plans AdComm Meet For Blood Cancer Candidate
- TG Therapeutics Inc (NASDAQ: 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.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: Biotech News Health Care Small Cap FDA Movers Trading Ideas General
