Why TG Therapeutics Is Plunging More Than 40% Today
Shares of biopharma outfit TG Therapeutics (NASDAQ: TGTX) are down to the tune of 43.4% as of 11:38 a.m. ET Tuesday after the company announced the U.S. Food and Drug Administration has scheduled a meeting that casts doubt on the approval of a key drug in its pipeline.
It's not a rejection of the therapeutic in question, to be clear. But it doesn't bode well for the drug.
On Tuesday, TG Therapeutics announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) has scheduled a meeting specifically to discuss the company's cancer-fighting combination of ublituximab and Ukoniq, aka umbralisib. The measure doesn't inherently indicate that the therapy aimed at chronic lymphocytic leukemia and small lymphocytic lymphoma can't or won't be approved. The ODAC meeting, however, is not a typical stage of the drug approval process. Such meetings are generally convened only when unexpected questions about efficacy, safety, or trial data itself surface.
Source Fool.com
