Jul 07, 2026
Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
Jun 19, 2026
Retrospective study analyzed longitudinal data from six immunotherapy-naive MuSK-MG patients over 2013-2024, finding significant positive correlation between MuSK antibody levels and disease severity as measured by MG-ADL scores. The correlation was specific to MuSK antibodies, with total IgG showing no independent relationship.
May 04, 2026
A retrospective study found that myocarditis within the first month after immune checkpoint inhibitor initiation was linked to higher mortality risk. The analysis identified 4,635 cases in VigiBase.
Apr 29, 2026
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Feb 17, 2026
BioNxt Solutions Inc. receives European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology, providing protection across up to 39 European Patent Convention states through at least June 14, 2043.
Dec 11, 2025
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.