What happened
Shares of biopharmaceutical company TG Therapeutics (TGTX -0.50%) climbed 63.37% on Thursday. The stock rose more than $3 on Thursday after closing on Wednesday at $5.16. It opened on Thursday at $5.83, and shortly before 2 p.m. ET jumped to a daily high of $8.44 before closing at $8.43. The stock has a 52-week low of $3.48 and a 52-week high of $33.87. The stock is down more than 55% so far this year.
So what
TG Therapeutics focuses on therapies to treat B-cell diseases. The company released its third-quarter earnings before the market opened on Thursday, but the rocket ship move upward had little to do with the company's financials and a lot to do with an announcement regarding its lead therapy, Ublituximab, a monoclonal antibody, to treat relapsed multiple sclerosis.
The company said that the Food and Drug Administration (FDA) had accepted the company's Biologics License Application (BLA) for Ublituximab and had set a Prescription Drug User Fee Act goal date of Dec. 28. With that news, TG Therapeutics said it is now focusing on the therapy's launch. It would be the company's first marketed drug and represents a big turnaround after the FDA withdrew its approval for a New Drug Application for lymphoma therapy Ukoniq last May because of safety concerns.
Now what
If Ublituximab is approved, TG Therapies goes from a clinical-stage biotech company to a commercial one, which is why investors were excited on Thursday. In the third-quarter report, the company said it lost $35.8 million in the quarter and had $$197.7 million in cash, enough, it said, to fund operations into 2024. The company appears confident of Ublituximab's approval after the monotherapy showed a superior performance to teriflunomide to treat MS in the Ultimate I and II trials for Ublituximab.
