Vera Therapeutics says TRUTAKNA met all endpoints in final ORIGIN 3 IgA nephropathy analysis
Vera Therapeutics announced that TRUTAKNA (atacicept-vymj) met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial in adults with IgA nephropathy at risk for disease progression. The company reported a placebo-adjusted 52-week eGFR change of 5.6 mL/min/1.73m2 and a 76% reduction in risk of composite kidney disease progression, and plans to submit a supplemental BLA to the FDA in Q4 2026.
Key points
- Final analysis set of 428 patients; 52-week eGFR treatment effect of 5.6 mL/min/1.73m2 versus placebo (p<0.0001)
- Composite kidney disease progression through 104 weeks: 11 events on TRUTAKNA versus 38 on placebo, hazard ratio 0.24
- Company plans to submit supplemental BLA to FDA in Q4 2026 for full approval, and reported over 350 patient start forms in the first ten weeks
- Overall adverse event and infection rates were similar to placebo; infections were reported in 32% of TRUTAKNA patients versus 28% of placebo
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 15, 2026.
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