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.
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