ublituximab subcutaneous / TG Therap - LARVOL DELTA

Subcutaneous BRIUMVI (GlobeNewswire) - "Top-line Phase 3 data is expected year-end 2026 or early 2027."

P3 data: top line • Immunology • Multiple Sclerosis

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: TG Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

TG Therapeutics Announces Positive Results from Phase 1 Trial Evaluating Subcutaneous BRIUMVI (ublituximab-xiiy) (TG Therapeutics Press Release) - "To date, over 100 patients have been treated in the trial, including more than 80 patients who received subcutaneous BRIUMVI across multiple dose levels....The overall concentration-time profile of subcutaneous BRIUMVI was consistent with expectations for a subcutaneous formulation, with a gradual absorption phase and lower peak concentrations relative to IV, and linear pharmacokinetics were observed over the entire dose range evaluated. Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration, with the lower bound of the 95% confidence interval exceeding 55%....Final data through 24-weeks from this Phase 1 trial are expected to be presented at a future medical meeting."

P1 data • Multiple Sclerosis

TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial (The Manila Times) - "In an ongoing Phase 1 study evaluating subcutaneous BRIUMVI, 11 patients with AChR-antibody-positive MG (mean age 74, 73% male) received subcutaneous BRIUMVI across cohorts that demonstrated exposure at least equivalent to the approved IV BRIUMVI regimen. At baseline, patients had clinically meaningful disease burden, with mean baseline Myasthenia Gravis Activities of Daily Living (MG-ADL) of 8.24 (range 6 - 13) and mean baseline Quantitative Myasthenia Gravis (QMG) score of 12.0 (range 7 - 22)...At Week 24, 82% of patients achieved the Minimal Clinically Important Difference (MCID) in MG-ADL, defined as a decrease of ≥ 2, with a median time to MCID of 30 days; Overall, a mean 4.6 point improvement in MG-ADL was observed at Week 24...The Phase 2 trial is expected to enroll approximately 120 patients. All enrolled patients will first receive a single induction cycle of efgartigimod, consisting of four weekly infusions."

New P2 trial • P1 data • Myasthenia Gravis

The Phase 3 trial is a randomized, open-label, parallel-group, multicenter trial designed to evaluate a quarterly and every other month dosing regimen of subcutaneous BRIUMVI compared to the approved IV regimen of BRIUMVI in adults with RMS (TG Therapeutics Press Release) - "The Phase 3 trial has completed enrollment, and topline results are expected in late 2026 or early 2027."

Enrollment closed • P3 data: top line • Multiple Sclerosis

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 | Active, not recruiting | Sponsor: TG Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • CNS Disorders • Multiple Sclerosis

TG Therapeutics Announces Completion of Enrollment for the Phase 3 Trial Evaluating Subcutaneous BRIUMVI (GlobeNewswire) - "This is a Phase 3, non-inferiority, randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous BRIUMVI compared to IV BRIUMVI in adult participants with RMS....Top-line data expected year-end 2026/ first quarter 2027."

Enrollment closed • P3 data: top line • Multiple Sclerosis

TG1101-RMS-SC201: A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability via Autoinjector Device versus Syringe in Patients with Multiple Sclerosis (clinicaltrialsregister.eu) - P1/2 | N=120 | Not yet recruiting | Sponsor: Tg Therapeutics Inc.

New P1/2 trial • CNS Disorders • Multiple Sclerosis

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 • Trial initiation date • CNS Disorders • Multiple Sclerosis

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov) - P2 | N=350 | Not yet recruiting | Sponsor: TG Therapeutics, Inc.

New P2 trial • CNS Disorders • Multiple Sclerosis

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