Vera Therapeutics: análise final do ORIGIN 3 da TRUTAKNA mostra estabilização da eGFR e redução de 76% no risco de progressão renal

The ORIGIN 3 final efficacy analysis (n=428) met all prespecified endpoints, demonstrating true eGFR stabilization and a 76% reduction in composite kidney disease progression events through two years. Vera plans to submit a supplemental BLA for full approval in Q4 2026 based on these confirmatory results.

Fatos principais

Arquivado: 15 de set. de 2026, 10:45
Evento: Resultados topline
Direção: Positivo
Empresa: VERAVera Therapeutics
Ativo: atacicept
Fonte: SEC 8-K
Confiança: Com fonte
Variação do EGFR em 52 semanas: -0.1 vs -5.7 mL/min/1.73m² (p<0.0001)
inclinação da EGFR em 104 semanas: -0.6 vs -5.6 mL/min/1.73m²/ano (p<0.0001)
HR de progressão composta: 0.24 (redução de risco de 76%, p<0.0001)
diálise transplante óbito: 0 vs 8 eventos

Trecho da fonte

EX-99.1 2 d32300dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Vera Therapeutics Announces TRUTAKNA ™ (atacicept-vymj) Stabilized eGFR and Prevented Kidney Disease Progression Through Two Years in ORIGIN 3 Final Efficacy Analysis in IgA Nephropathy • TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met all prespecified endpoints, including unprecedented placebo-adjusted estimated glomerular filtration rate (eGFR) and composite kidney disease progression benefits. • Favorable safety profile, and generally comparable to placebo. • Strong commercial launch momentum with over 350 patient start forms generated in the first ten weeks. • Plan to submit supplemental BLA to the U.S. Food and Drug Administration (FDA) for full approval in Q4 2026. BRISBANE, Calif., September

SEC 8-K