Short answer
Vera Therapeutics, Inc. (VERA) filed an 8-K current report with the SEC on September 15, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item EX-99.1 (Exhibit EX-99.2). TRUTAKNA preserved kidney function: eGFR change +2 vs -5.7 mL/min/1.73m² at 52 weeks.
Vera Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- TRUTAKNA preserved kidney function: eGFR change +2 vs -5.7 mL/min/1.73m² at 52 weeks
- Annualized eGFR decline improved to -0.6 vs -5.6 mL/min/1.73m²/year through 104 weeks
- Kidney progression events fell to 11 vs 38, with hazard ratio 0.24 and 76% risk reduction
- Dialysis, transplant, or death occurred in 0 vs 8 patients through 104 weeks
- Favorable safety profile comparable to placebo, with no opportunistic infections or clinically relevant hypogammaglobulinemia
Item EX-99.1 · Exhibit EX-99.2
- ORIGIN 3 met all prespecified endpoints in 428 patients, supporting TRUTAKNA’s potential transition from accelerated to full approval
- eGFR decline through 104 weeks: -0.6 vs -5.6 mL/min/1.73m²/year, a 5.0 treatment effect with p<0.0001
- Composite kidney progression: 11 vs 38 events, hazard ratio 0.24 and 76% risk reduction through 104 weeks
- No dialysis, transplant, or death events with TRUTAKNA versus 8 with placebo through 104 weeks
- Supplemental BLA planned for Q4 2026, while 350+ patient start forms in ten weeks indicate early launch traction
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