VERA Vera Therapeutics

atacicept · NCT04716231 registry update

enrollment: 376 → 428; primary_outcomes: ['Change from baseline in urine protein to creatinine ratio (UPCR)'] → ['Percentage Change From Baseline in Urine Protein to Creatinine Ratio (UPCR)']

Vera Therapeutics: TRUTAKNA ORIGIN 3 final analysis shows eGFR stabilization, 76% kidney progression risk reduction

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.

Vera Therapeutics: TRUTAKNA (atacicept) granted accelerated FDA approval in IgAN

FDA granted accelerated approval for TRUTAKNA to reduce proteinuria in adults with primary IgAN at risk for disease progression. The approval is based on the ORIGIN Phase 3 trial showing 46% proteinuria reduction from baseline. Vera aligned with FDA on an earlier ORIGIN 3 final efficacy analysis to support potential full approval, with results expected in Q3 2026 and sBLA submission in Q4 2026.

Vera Therapeutics, Inc. Class A · FDA approves Trutakna (atacicept-vymj)

FDA lists Trutakna (atacicept-vymj) as novel drug approval #24 of 2026 on 2026-07-07: To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression

Vera Therapeutics: FDA grants priority review to atacicept BLA; PDUFA July 7, 2026

FDA granted priority review to the atacicept BLA for accelerated approval in adult IgAN and set a PDUFA target action date of July 7, 2026. The company remains on track for a potential U.S. commercial launch in mid-2026, pending approval. The strong balance sheet is expected to fund operations through approval and launch.

Vera Therapeutics: FDA sets July 7, 2026 PDUFA for atacicept IgAN BLA

FDA granted priority review to the atacicept BLA and assigned a PDUFA target action date of July 7, 2026. The company plans a potential U.S. commercial launch in mid-2026 if approved. Positive Phase 3 ORIGIN 3 data were presented at ASN Kidney Week and published in NEJM.

Vera Therapeutics: ORIGIN 3 IgAN data at ASN Kidney Week 2025

Primary endpoint results from the pivotal ORIGIN Phase 3 trial of atacicept in IgAN will be presented as a late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 on November 6, 2025. Two additional posters are also scheduled. The company plans to submit a BLA for atacicept in IgAN via the Accelerated Approval Program in Q4 2025.