Sobi (SOBI.ST) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli or pegcetacoplan for the treatment of adult and adolescent patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. The CHMP recommendation is based on positive results from the Phase 3 VALIANT study.
The company said the approval decision by European Commission is expected in the first quarter of 2026. Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.
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Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.