Vertex Pharmaceuticals reported that its late-stage study of povetacicept in IgA nephropathy is progressing without issues, according to CEO and President Reshma Kewalramani. During the company’s full-year 2025 earnings presentation, Kewalramani stated, “They have not asked us to change anything in the study,” referring to the independent data board overseeing the RAINIER trial. This suggests that the trial is proceeding as planned.
The RAINIER study, which was fully enrolled last November, compares povetacicept against placebo with a primary focus on the 24-hour urine protein-to-creatinine ratio (UPCR), an important indicator of disease severity and progression. Data from this trial are expected in the first half of this year and will support Vertex’s rolling approval application with the FDA. The company used a priority review voucher for this submission.
Analysts at BMO Capital Markets commented after Thursday’s call, “Povetacicept presents a significant opportunity for Vertex, which could be validated further by interim data in IgAN.” They also described the upcoming UPCR results as “critical” for Vertex due to growing competition in treatments for IgA nephropathy.
Otsuka recently received FDA approval for its anti-APRIL antibody Voyxact. Vera Therapeutics is also advancing atacicept, a fusion protein that showed a 46% reduction in proteinuria during Phase 3 trials last November.
Vertex aims to expand povetacicept beyond IgAN into other B cell-mediated diseases. Kewalramani said it will be tested in neurology through a study in generalized myasthenia gravis (gMG). She added that Vertex is developing povetacicept for primary membranous nephropathy as well. BMO analysts noted that while expansion into gMG is promising, competition has increased significantly in recent years.
In financial results for the fourth quarter, Vertex reported $3.19 billion in revenue—a 10% increase from last year—slightly surpassing analyst expectations of $3.18 billion. The company’s cystic fibrosis treatment Trikafta generated $2.57 billion, while Alfytrek contributed $380 million.
Sales of Journavx, Vertex’s non-opioid painkiller, reached $26.7 million for the quarter but fell short of analyst forecasts by 18%. BMO expects only incremental growth for Journavx sales during the first half of 2026.
