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.
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.
Vertex Pharmaceuticals reported fourth quarter 2025 revenue of $3.19 billion, up 10% year-over-year, and provided full year 2026 revenue guidance of $12.95 billion to $13.1 billion with over $500 million expected from non-CF products.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07501702 |
A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis |
RECRUITING | PHASE2 |
| NCT07204275 |
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) |
RECRUITING | PHASE2/PHASE3 |
| NCT05757570 |
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
