Sobi (STO: SOBI), a Sweden-based global biopharma company, announced on that the company has received a positive opinion from the European Medicines Agency s Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Aspaveli (pegcetacoplan), intended for the treatment of adult and adolescent patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), rare and debilitating kidney diseases that can lead to kidney failure.

This positive opinion from the CHMP is now referred to the European Commission for an approval decision that is expected to be revealed in the first quarter of 2026.

The company and its partner Apellis Pharmaceuticals Inc have global co-development rights for systemic pegcetacoplan.

CHMP recommendation is based on positive results from the Phase 3 VALIANT study, in which Aspaveli demonstrated benefits across three key markers of disease, including significant reduction in proteinuria, stabilisation of kidney function and substantial clearance of C3 deposits. These positive results were recently published in The New England Journal of Medicine.

Lydia Abad-Franch, MD, Sobi head of R&D and Medical Affairs, and chief medical officer, said: "The CHMP's positive opinion for Aspaveli represents an important milestone for people living with C3G or primary IC-MPGN in Europe, two severe and rare kidney diseases with limited treatment options and a high risk of kidney failure. If approved, Aspaveli would become the first therapy for patients 12 years and older with these serious kidney diseases, which often affect adolescents and young adults. We look forward to the European Commission's decision and to the opportunity to make a meaningful difference in the lives of patients and their families."