TG Therapeutics Shares Drop 38% After Plans for Advisory Meeting
By Chris Wack
TG Therapeutics Inc. shares were down 38%, to $14.46 after the
company said the U.S. Food and Drug Administration notified it that
it plans to host a meeting of the Oncologic Drugs Advisory
Volume for the stock was 9.3 million shares at 10:25 a.m. ET,
compared with its 65-day average volume of 1.1 million shares. The
stock hit its 52-week low of $12.62 earlier in the session.
The company said the meeting is in connection with the FDA's
review of the pending Biologics License Application/supplemental
New Drug Application for the combination of ublituximab and Ukoniq
umbralisib U2 combination for the treatment of adult patients with
chronic lymphocytic leukemia and small lymphocytic lymphoma.
The Oncologic Drugs Advisory Committee generally reviews and
evaluates data concerning the safety and effectiveness of marketed
and investigational human drug products for use in the treatment of
cancer and makes appropriate recommendations to the Commissioner of
Food and Drugs. Although the FDA will consider the recommendation
of the ODAC committee, the final decision regarding the approval of
a product is made solely by the FDA.
The FDA has notified the company that potential questions and
discussion topics for the ODAC include 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 or follicular
lymphoma. The overall safety profile of the U2 regimen, including
adverse events, is expected to be reviewed.
The company said the FDA's concern giving rise to the ODAC
meeting appears to stem from an early analysis of overall survival
from the trial.
The date of the ODAC meeting hasn't yet been determined,
although the FDA has stated that it is targeting holding the ODAC
in March or April 2022. Given this timing, the company said it
believes it is unlikely that the FDA will make a decision on the
BLA/sNDA by the PDUFA goal date of March 25, 2022.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
November 30, 2021 10:49 ET (15:49 GMT)
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