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Vertex Pharmaceuticals’ late-stage study of povetacicept in IgA nephropathy has a “clean bill of health so far,” building up to a highly anticipated readout in the first half of this year as the biotech continues to slowly accrue sales for its nonopioid analgesic Journavx.
Speaking to investors on Thursday to present the company’sfull-year 2025 earningsresults, Vertex CEO and President Reshma Kewalramani could only reveal that the study, called RAINIER, is ongoing and is being monitored by an independent data board. “They have not asked us to change anything in the study,” she noted, which suggests that the trial is proceeding smoothly.
In November last year, Vertex announced that it had fully enrolledRAINIER, which is comparing povetacicept against placebo, looking primarily at 24-hour urine protein-to-creatinine ratio (UPCR), a key measure of disease severity and progression. Data are expected in the first half of this year, which will allow Vertex to complete its rolling approval application with the FDA.
The biotech used a priority review voucher for this submission, according to Kewalramani.
“Povetacicept presents a significant opportunity for Vertex, which could be validated further by interim data in IgAN,” analysts at BMO Capital Markets wrote in an investor note after the company call on Thursday. In particular, the firm called the upcoming UPCR results “critical” for Vertex amid increasing competition in the IgAN space.
In November last year, for instance, Otsukawon the FDA’s nodfor its anti-APRIL antibody Voyxact. Following close behind—and posing another market challenge to Vertex—is Vera Therapeutics and its fusion protein atacicept, which in the same month demonstrated a 46% reduction in proteinuria, according to aPhase 3 readout.
Beyond IgAN, Vertex is also positioning povetacicept as a “pipeline-in-a-product for multiple B cell-mediated diseases,” Kewalramani said, revealing that the company plans to expand the drug into neurology with a study in generalized myasthenia gravis (gMG).
“Expansion in gMG seems interesting,” BMO wrote on Thursday, “but competition has grown significant in recent years.” Vertex is also developing povetacicept for primary membranous nephropathy.
In the fourth quarter, Vertex made $3.19 billion in revenue, a 10% year-on-year increase but a slim beat of the analyst consensus of $3.18 billion. Cystic fibrosis continued to be the company’s main money-maker: Trikafta brought in $2.57 billion while Alfytrek made $380 million.
Sales for the company’s non-opioid painkiller Journavx stalled at $26.7 million for the quarter, falling 18% behind analyst forecasts. BMO doesn’t expect the painkiller to see explosive growth in the coming quarters, noting in its Thursday note that the product’s sales will most likely see an “incremental” increase in the first half of 2026.