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BioWorld - Thursday, December 18, 2025
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Home » Open label: Extension of PDUFA less troubling as TG’s ublituximab makes headway in regulatory talks
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Open label: Extension of PDUFA less troubling as TG’s ublituximab makes headway in regulatory talks

Nov. 11, 2022
By Randy Osborne
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
BioWorld Clinical Regulatory Immune

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