Atacicept - (PIONEER)

November 5, 2026: Vera Therapeutics (NASDAQ: VERA) reported that TRUTAKNA (atacicept-vymj) is gaining early U.S. launch traction after FDA accelerated approval on July 7, 2026 to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. The company said it has received about 700 patient start forms and recorded $10.3 million in Q3 net product revenue.

For ORIGIN 3 in primary IgAN, final efficacy data presented at ASN Kidney Week 2026 and published in The New England Journal of Medicine showed TRUTAKNA met all prespecified endpoints. Through 104 weeks, annualized eGFR slope was -0.6 mL/min/1.73m²/year versus -5.6 for placebo, a 5.0 mL/min/1.73m²/year treatment difference (p<0.0001). The company also cited a 76% reduction in risk of composite kidney disease progression versus placebo and said safety was favorable and generally comparable to placebo.

Regulatory: Vera completed an sBLA submission to FDA on November 3, 2026 seeking full approval of TRUTAKNA in adults with primary IgAN; potential full approval is expected in mid-2027, subject to FDA review. An EMA Marketing Authorisation Application is planned for Q1 2027.

Pipeline: Interim Phase 2 PIONEER basket trial results in adult IgAN and primary membranous nephropathy, plus pediatric IgAN evaluation plans, were also presented at ASN Kidney Week 2026.