What's Going On With TG Therapeutics Shares

TG Therapeutics Inc TGTX shares are trading higher by 9.34% to $9.25 Thursday morning. The company on Wednesday revealed FDA approval of ublituximab.

What's Happening?

TG says approval was granted for this indication based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.

Results from the ULTIMATE I & II trials were recently published in August 2022 in The New England Journal of Medicine.

TG says BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose.

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Michael S. Weiss, the company's Chairman and Chief Executive Officer, stated, "Today's FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of BRIUMVI."

"We believe in the importance of treatment alternatives for patients and believe the profile of BRIUMVI offers unique attributes to patients and physicians alike. We have built a strong commercial team with deep knowledge of the MS landscape and look forward to launching in Q1 2023," Weiss stated.

According to data from Benzinga Pro, TGTX has a 52-week high of $20.69 and a 52-week low of $3.48.