FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
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.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06983028 |
Atacicept in Multiple Glomerular Diseases |
RECRUITING | PHASE2 |
