ublituximab subcutaneous / TG Therap - LARVOL DELTA

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: TG Therapeutics, Inc.

Head-to-Head • New P3 trial • CNS Disorders • Multiple Sclerosis

TG Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "2025 Development Pipeline Anticipated Milestones: Commence pivotal program of subcutaneous ublituximab; Commence a pivotal program based on data from the ENHANCE trial with the goal of enhancing the patient experience on intravenous BRIUMVI; Enroll participants into the ongoing trial evaluating BRIUMVI in autoimmune diseases outside of MS; Enroll participants into the Phase 1 azer-cel trial in autoimmune disease, beginning with progressive forms of MS; Present updated data at major medical conferences throughout the year."

Clinical data • Enrollment status • New trial • Immunology • Multiple Sclerosis

TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance (GlobeNewswire) - "BRIUMVI U.S. net product revenue of $72.6 million for the second quarter of 2024, representing >350% growth over the second quarter of 2023...Initiated a phase 1 clinical trial evaluating subcutaneous ublituximab in RMS, with the first patients now dosed. Received clearance by the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application for azer-cel in progressive forms of multiple sclerosis (MS)....Remaining 2024 Development Pipeline Anticipated Milestones: Present additional data from the ENHANCE Phase 3b CD20 switch trial."

IND • P3 data • Sales • Trial status • Immunology • Multiple Sclerosis