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Record mula sa primary source

Decision-gradeTopline na resulta

Vera Therapeutics: ipinakita ng final analysis ng TRUTAKNA ORIGIN 3 ang eGFR stabilization at 76% na pagbawas sa panganib ng progresyon ng sakit sa bato

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.

Mahahalagang fact

Na-file
Set 15, 2026, 10:45 AM
Kaganapan
Topline na resulta
Direksyon
Positibo
Kumpanya
VERAVera Therapeutics
Asset
atacicept
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Pagbabago ng EGFR sa 52 linggo
-0.1 kumpara sa -5.7 mL/min/1.73m² (p<0.0001)
Dahilis ng EGFR sa 104 linggo
-0.6 kumpara sa -5.6 mL/min/1.73m²/taon (p<0.0001)
HR ng pinagsamang pag-usad
0.24 (76% pagbawas ng panganib, p<0.0001)
Dialisis, transplant, kamatayan
0 kumpara sa 8 pangyayari

Sipi mula sa source

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

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Presentasyon sa kumperensyaSEC 8-K