One year of treatment with inebilizumab eased symptoms and improved daily functioning for people with generalized myasthenia gravis (gMG) positive for antibodies against the acetylcholine receptor (AChR), according to new data from the Phase 3 MINT clinical trial. Amgen, the company developing inebilizumab, will present the new…

Cartesian Therapeutics has aligned with the U.S. Food and Drug Administration (FDA) on the design of the planned Phase 3 AURORA trial that will test its investigational cell therapy Descartes-08 in people with myasthenia gravis (MG). The FDA, under its special protocol assessment process, provided written agreement…

Amgen’s antibody-based therapy inebilizumab reduces the severity of generalized myasthenia gravis (MG), according to top-line data from a Phase 3 clinical trial. Dubbed MINT (NCT04524273), the study showed inebilizumab’s therapeutic efficacy in gMG patients who test positive for self-reactive antibodies against the acetylcholine receptor (AChR) or muscle-specific…

Treatment with nipocalimab led to significant reductions in disease severity among people with generalized myasthenia gravis (gMG), as assessed by a drop in the MG Activities of Daily Living (MG-ADL) score, according to top-line data from a pivotal Phase 3 trial. Findings from the trial, dubbed VIVACITY-MG3…

Nipocalimab, an investigational therapy for people with generalized myasthenia gravis (gMG), significantly eased disease severity compared with a placebo, according to top-line data from a pivotal Phase 3 clinical trial. Johnson & Johnson, the therapy’s developer, also plans to engage with regulatory authorities worldwide to present…

Treatment with rozanolixizumab — an investigational therapy being developed by UCB for generalized myasthenia gravis (gMG) — worked in a clinical trial to ease symptom severity for a subset of patients who were positive for muscle specific kinase (MuSK) antibodies. That’s according to analyses from the Phase…

Immunovant is moving forward with its Phase 3 clinical trial in the U.S. to evaluate the investigational myasthenia gravis (MG) therapy batoclimab in the first half of this year. The announcement came after the company reached an agreement with the division of neurology within the U.S. Food…

The first participant has been dosed in a Phase 3 clinical trial testing the efficacy and safety of batoclimab (HBM9161) in people with generalized myasthenia gravis (gMG) in China. “The first patient first dosing in the phase III study brings us one step closer to deliver the novel therapeutic…

Ultomiris (ravulizumab-cwvz) rapidly and sustainably eased symptom severity in adults with generalized myasthenia gravis (gMG), according to top-line data from a Phase 3 trial. Alexion Pharmaceuticals, the therapy’s developer, now plans to submit regulatory applications requesting approval of Ultomiris for gMG in the U.S., Europe, and Japan, later…

Argenx is one step closer to launching a global Phase 3 trial to evaluate the potential of its therapy candidate efgartigimod (ARGX-113) for generalized myasthenia gravis (gMG). Following feedback from the U.S. Food and Drug Administration in June, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan…