TG Therapeutics Touts Encouraging Data From Multiple Sclerosis Candidate

TG Therapeutics Inc TGTX announced results from the ULTIMATE I & II Phase 3 trials evaluating ublituximab for relapsing forms of multiple sclerosis (RMS), were published in The New England Journal of Medicine (NEJM).
In the ULTIMATE I study, treatment with ublituximab resulted in an Annualized Relapse Rate (ARR) of 0.08, compared to 0.19 for Sanofi SA's SNY Aubagio (teriflunomide). In the ULTIMATE II trial, the rate was 0.09 versus 0.18.
Related: TG Therapeutics Retracts FDA Request For Ublituximab / Ukoniq Combo In Blood Cancers
In ULTIMATE I, No Evidence of Disease Activity (NEDA) was observed in 44.6% of ublituximab-treated patients and 15% of the teriflunomide-treated patients, with 43% vs. 11.4% in the ULTIMATE II.
In the prespecified pooled analysis, 5.2% of the participants in the ublituximab group had a worsening disability confirmed at 12 weeks, compared with 5.9% of the participants in the teriflunomide group and 3.3% vs. 4.8% at 24 weeks. These results were not considered to be significantly different between treatment groups.
Ublituximab application is under review by the FDA and European Medicines Agency, with the PDUFA goal date of December 28, by the FDA.
If approved, ublituximab will be the first B-cell therapy for use in RMS patients that can be given as a 1- hour infusion every six months following the first dose.
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