Also known as: APRIL
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
