Vera's TRUTAKNA Meets All Endpoints in Final ORIGIN 3 Kidney Disease Trial
- Vera Therapeutics reported that TRUTAKNA (atacicept) met all prespecified endpoints in the final, two-year efficacy analysis of the Phase 3 ORIGIN 3 trial in adults with primary IgA nephropathy (IgAN), a chronic autoimmune kidney disease.
- Atacicept is a BAFF/APRIL-targeting fusion protein; treatment stabilized kidney function and reduced the risk of kidney-related death and other disease complications.
- Statistically significant, hierarchically tested reductions were achieved across proteinuria, galactose-deficient IgA1 (Gd-IgA1) levels, and hematuria.
- eGFR trends aligned with the KDIGO clinical treatment goal of slowing kidney-function decline toward the normal physiologic rate.
- TRUTAKNA already holds FDA accelerated approval for IgAN, granted July 2026; these final two-year data are intended to support Vera's case for full, non-accelerated approval.
Full, hierarchically-tested endpoint clearance across proteinuria, Gd-IgA1, and hematuria is exactly the kind of data package payers and prescribers weight most heavily when a drug's approval is still accelerated and provisional — this reads as Vera's strongest case yet for converting TRUTAKNA to full approval and retiring the confirmatory-trial overhang that's been sitting on the stock. That matters disproportionately for a single-asset company: Vera has no second program to fall back on if ORIGIN 3 had disappointed, so a clean conversion is existential, not incremental. It also sharpens the IgAN scramble — Travere's sparsentan (Filspari), Novartis's atrasentan (Vanrafia), and Otsuka's entrants are all fighting for first-line real estate in a field that's gone from orphan afterthought to genuinely contested in under two years. Durable, un-caveated data is now the differentiator, not novelty of mechanism alone.
Vera kidney drug Trutakna shows strong final results in Phase 3 trial ↗