TG Therapeutics Inc (TGTX)

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TG Therapeutics (TGTX)
First up is TG Therapeutics, a biopharma research firm working on new treatments for B-cell diseases. These are serious autoimmune conditions featuring a loss of B-cell tolerance along with inappropriate production of various antibodies. Diseases in this category include multiple sclerosis (MS) and rheumatoid arthritis (RA). TG has a wide ranging pipeline, featuring several drug candidates in early investigational or clinical stages – and one drug on the cusp of FDA approval.
That leading candidate, ublituximab, is a glycoengineered monoclonal antibody designed to target ‘a unique epitope on CD20-expressing B-cells.’ This drug action is used in the treatment of relapsing forms of MS.
Ublituximab has recently completed two Phase 3 trials, Ultimate I and Ultimate II, and based on those results the company has submitted the Biologics License Application (BLA) to the FDA. The regulatory agency has accepted the BLA and given TG a PDUFA goal date of December 28 this year.
The ublituximab FDA process is the main news for TG, and the company is preparing for a commercial launch of the drug early next year. While this will lead to increased G&A expenses in 4Q22, the company is confident that its current cash resources, $197.7 million as of the end of Q3, can carry operations – including the ublituximab commercial launch – into 2024.
Among the bulls is Ladenburg analyst Matt Kaplan, who believes ublituximab shows potential to lead its niche once approved.

“We look forward to the FDA approval of ubli for treating MS in December 2022… During the 3Q22 conference call, TG noted they have already completed a late-cycle meeting with the FDA, and labeling discussions recently commenced. We are encouraged by the commencement of labeling discussions and currently expect a 1Q 2023 market launch. We continue to be impressed with the safety and efficacy profile ublituximab has demonstrated in the R-MS setting and believe it represents a best-in-class profile,” Kaplan opined.
Kaplan puts a Buy rating on TGTX shares, and matches that with a $22 price target indicating confidence in a one-year upside of 168%. (To watch Kaplan’s track record, click here)
Overall, with 4 recent analyst reviews on record here, all positive, TGTX shares get a Strong Buy consensus rating. The stock is selling for $8.20, and its $19.75 average price target implies a gain of ~141% by the end of next year. (See TGTX stock forecast on TipRanks)