Roche and Ionis reported that the 459-patient randomized IMAgINATION Phase 3 trial met its prespecified 37-week proteinuria endpoint in primary IgA nephropathy. Monthly subcutaneous sefaxersen significantly reduced 24-hour urine protein-to-creatinine ratio versus placebo. The…
In the 428-patient final efficacy analysis of Phase III ORIGIN 3, atacicept-vymj preserved estimated glomerular filtration rate versus placebo through two years in adults with primary IgA nephropathy. Mean eGFR change at Week 52…
Climb Bio reported initial Phase I healthy-volunteer data for CLYM116, a pH-dependent APRIL “sweeper” antibody licensed from Beijing Mabworks. A single 320-mg subcutaneous dose produced greater than 90% free-APRIL suppression through week 10 and…
Otsuka presented complete 24-month Phase III VISIONARY results showing a prespecified annualized eGFR slope of +0.3 mL m²/year with VOYXACT versus −4.2 with placebo, a treatment difference of +4.5 with p
The U.S. FDA granted accelerated approval to TRUTAKNA™ (atacicept-vymj) for adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. Developed by Vera Therapeutics, TRUTAKNA is the first therapy to simultaneously…
