Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization and TG Therapeutics (NASDAQ: TGTX), today announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQ™ (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.
https://finance.yahoo.com/news/samsung-biologics-tg-therapeutics-expand-110000287.html
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