Vertex Kidney Drug Povetacicept Hits Phase 3 Goal, FDA Grants Rolling Review
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 Pharmaceuticals announced that its ongoing Phase 3 RAINIER trial of povetacicept in immunoglobulin A nephropathy (IgAN) met its primary objective, achieving a 52% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36. The trial also demonstrated a statistically significant 49.8% UPCR reduction compared to placebo, with 85.1% of patients with baseline hematuria achieving resolution. Patients treated with povetacicept experienced a 77.4% reduction from baseline in serum galactose-deficient IgA1.
The FDA has granted a rolling review of the Biologics License Application for povetacicept, with Vertex planning to complete its full submission by the end of March. The positive data has been described as a "clear win" for Vertex and supportive of a best-in-class profile for the BAFF/APRIL inhibitor class.
Vertex shares rose following the news, trading up 6.32% at $489.99 during premarket trading. The stock also hit a 5-week high after an upgrade from Oppenheimer, which raised its rating to "Outperform" with a price target of $540, driven by growing excitement for Vertex's emerging renal pipeline. Barclays raised its target to $606, and UBS lifted its view to $545.
The CEO stated that the renal pipeline is "emerging as our fourth vertical alongside CF, heme, and pain as a key engine for Vertex's next decade of growth." The Chief Commercial Officer added that the company anticipates the renal franchise will "ultimately rival the scale of our CF business." Management noted that povetacicept is a "pipeline in a product" that can treat IgA nephropathy, membranous nephropathy, and potentially myasthenia gravis.