All gains made throughout the summer have vanished as the BioWorld Cancer Index (BCI) has hit its lowest point in 2022. Down 41.9% this year, BCI diverged in October from the path taken by both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), both of which are moving upward. Still, NBI is down 7.8% and DJIA is down 5.4% for the year.
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma.
Contrary to the broader markets, BioWorld’s Cancer Index is down by 22% this year, losing more than 7% throughout the month of July, despite oncology driving several high-money deals and accounting for 38%, the lion’s share, of financings. Both the Nasdaq Biotech Index and the Dow Jones Industrial Average are tracking similarly for the year, and are up by 13.2% and 15.2%, respectively, as of Aug. 10.
Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
The exceptional and speedy response in bringing safe and effective vaccines and therapeutics to combat COVID-19 has kept investors engaged and supportive. As a result, not only have companies involved in this research and development benefited, but so has the sector as a whole. Those biopharma companies have enjoyed significant jumps in their share values, with the BioWorld Drug Developers index closing up 4.6% in December and up 29% for 2020.
The BioWorld Drug Developers index is currently tracking up more than 9% in value so far this month and is on target, with a handful of trading days left before the end of the year, to close up over 35% for 2020, well ahead of the general markets.
As the year draws to a close, there is no doubt that investors have been keeping a close watch on emerging companies developing cancer therapies as well as those with new vaccines and treatments aimed at defeating COVID-19.
Both phase III studies of ublituximab, an anti-CD20 monoclonal antibody from TG Therapeutics Inc., of New York, met their primary endpoints of significantly reducing the annualized relapse rate in multiple sclerosis (MS) patients. Company stock (NASDAQ:TGTX) received a solid bump Dec. 10 as shares closed 40.85% higher at $41.72. T
