other material
confidence high
sentiment positive
materiality 0.95
TRUTAKNA meets all endpoints in ORIGIN 3 final analysis; stabilizes eGFR, cuts progression risk 76%
Vera Therapeutics, Inc.
- Mean eGFR change at 52 weeks: TRUTAKNA -0.1 vs placebo -5.7 mL/min/1.73m² (treatment effect 5.6, p<0.0001).
- Annualized eGFR slope to 104 weeks: -0.6 vs -5.6 mL/min/1.73m²/yr (effect 5.0, p<0.0001).
- Composite kidney progression events: 11 vs 38; HR 0.24 (95% CI 0.12-0.48), 76% risk reduction (p<0.0001).
- No dialysis/transplant/death events in TRUTAKNA arm vs 8 on placebo through 104 weeks; safety comparable to placebo.
- Over 350 patient start forms in first 10 weeks of launch; sBLA for full FDA approval planned Q4 2026.
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