IgA nephropathy is a primary glomerular disease characterized by mesangial deposition of immunoglobulin A in the kidneys, causing hematuria, proteinuria, and variable progression to chronic kidney disease. Clinical course is heterogeneous, ranging from stable kidney function to progressive renal failure. It is one of the most common primary glomerulopathies worldwide.
Novartis beat second-quarter profit expectations as Kisqali, Kesimpta and Leqvio offset a 50% plunge in Entresto sales. The Swiss drugmaker maintained its full-year guidance and awaits late-stage data on three experimental drugs.
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.
Vertex Pharmaceuticals dominates cystic fibrosis therapies with TRIKAFTA/KAFTRIO generating $2.57 billion in Q4 2025 and ALYFTREK ramping to $380.1 million. The company posted strong free cash flow of $3.19 billion in 2025 and is expanding into pain, kidney disease, and gene-editing therapies.
Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
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.
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
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 |
|---|---|---|---|
| NCT07770815 |
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07757048 |
A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States |
COMPLETED | |
| NCT07754019 |
Serum and Urinary sCD163 in IgA Nephropathy |
ACTIVE_NOT_RECRUITING | |
| NCT07642050 |
A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy |
NOT_YET_RECRUITING | PHASE3 |
| NCT07634744 |
A Phase IIa Study in Primary IgA Nephropathy Patients |
COMPLETED | PHASE2 |
| NCT07541287 |
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy |
RECRUITING | PHASE2 |
| NCT07498335 |
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN |
RECRUITING | PHASE3 |
| NCT07481084 |
IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection |
NOT_YET_RECRUITING | |
| NCT07319585 |
Managed Access Programs for EXV811, Atrasentan |
AVAILABLE | |
| NCT07203404 |
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases. |
RECRUITING | EARLY_PHASE1 |
