FDA to hold ODAC meeting for TG Therapeutics' U2 BLA; PDUFA date likely extended

TG THERAPEUTICS, INC.

FDA notified TG Therapeutics it will host an ODAC meeting for the U2 BLA/sNDA for CLL/SLL.
ODAC meeting targeted for March or April 2022; March 25, 2022 PDUFA date unlikely to be met.
Early overall survival analysis showed HR 1.23 favoring control; excluding COVID deaths HR 1.04 (not significant).
Company affirms belief in UKONIQ's differentiated safety profile and that data support approval.
Conference call scheduled for November 30, 2021 at 8:30 AM ET to discuss regulatory updates.

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