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Vertex Pharmaceuticals, on March 9, 2026, reported positive Week 36 interim results from the Phase 3 RAINIER trial of povetacicept in immunoglobulin A nephropathy, or IgAN, and said it will complete its biologics license application by the end of March for potential U.S. accelerated approval.
In the interim analysis population of 199 patients, at Week 36, povetacicept met the primary endpoint, reducing 24-hour UPCR by 52.0% from baseline and 49.8% versus placebo. It also met both alpha-controlled secondary endpoints, with a 79.3% reduction versus placebo in serum Gd-IgA1 and hematuria resolution in 85.1% of treated patients versus 23.4% on placebo.
The data support Vertex’s regulatory filing for a late-stage IgAN asset dosed once every four weeks.
Operationally, the company said povetacicept was generally safe and well tolerated, with no serious adverse events related to treatment and no deaths in the trial. Vertex plans to use a priority review voucher to reduce FDA review time from 10 months to six. The 605-patient RAINIER trial remains ongoing, with final analysis at Week 104 based on total eGFR slope.
Sources: Reuters, Vertex Pharmaceuticals
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