Vera Therapeutics, Inc.

Vera Therapeutics Announces Positive ORIGIN 3 Final Efficacy Analysis of TRUTAKNA™ (atacicept-vymj) in IgA Nephropathy Presented at ASN Kidney Week 2026 and Published in the New England Journal of Medicine

Vera Therapeutics announced the final efficacy analysis of its Phase 3 ORIGIN 3 trial showing TRUTAKNA (atacicept-vymj) achieved statistical significance in all prespecified endpoints in adults with primary IgA nephropathy at risk of disease progression. The primary endpoint of proteinuria reduction at 36 weeks was met, with additional significant reductions in urine-protein-to-creatinine ratio, Gd-IgA1, and hematuria, plus a safety profile generally comparable to placebo (7% serious adverse events vs 15% on placebo). Results were presented at ASN Kidney Week 2026 and published in the New England Journal of Medicine. Vera plans to submit a supplemental BLA to the FDA in Q4 2026 targeting full approval of TRUTAKNA in 2027; an investor call was held at 4:30 PM EDT on October 22.

•10d ago

Vera Therapeutics Announces ORIGIN 3 Final Efficacy Analysis of TRUTAKNA™ (atacicept-vymj) in IgA Nephropathy Will be A Featured Late-breaking Oral Presentation at the Opening Plenary Session of ASN Kidney Week 2026

Vera Therapeutics announced that the final efficacy analysis of the Phase 3 ORIGIN 3 trial of TRUTAKNA in IgA nephropathy will be a featured late-breaking oral presentation at the ASN Kidney Week opening plenary on October 22, 2026. In total, five Vera-sponsored abstracts will be presented, including interim results from the adult IgAN and primary membranous nephropathy cohorts of the PIONEER Phase 2 basket trial. ORIGIN 3 is the confirmatory trial for TRUTAKNA's accelerated approval, so the upcoming data readout is a high-stakes catalyst; no efficacy figures were disclosed in this announcement.

•0mo ago

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

Vera Therapeutics' TRUTAKNA met all prespecified endpoints in the final efficacy analysis of the Phase 3 ORIGIN 3 trial in IgA nephropathy, with a 76% reduction in composite kidney disease progression risk (hazard ratio 0.24, p<0.0001) versus placebo across 428 patients. Kidney function was effectively stabilized: mean eGFR change at 52 weeks was -0.1 vs -5.7 for placebo (5.6 treatment effect), and the annualized eGFR slope through 104 weeks was -0.6 vs -5.6, aligning with the KDIGO physiologic-decline goal. No dialysis, transplant, or death occurred on drug through two years versus 8 on placebo. Safety remained generally comparable to placebo, and the commercial launch shows momentum with over 350 patient start forms in the first ten weeks plus paid claims and favorable initial payer policies. Vera plans to submit a supplemental BLA for full approval in Q4 2026 with potential FDA conversion in 2027 — the readout verifies the clinical benefit required to convert accelerated approval and removes the confirmatory-trial overhang on the flagship asset.

•1mo ago

Vera Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results

Vera Therapeutics announced the FDA accelerated approval of TRUTAKNA for adult patients with primary IgAN at risk of disease progression, marking the company's transition to a commercial-stage entity. The U.S. commercial launch is underway with TRUTAKNA positioned as the first and only therapy to inhibit both BAFF and APRIL in this indication. For the second quarter, the company reported a net loss of $109.5 million, or $1.52 per share, primarily due to increased commercial launch expenses, while maintaining a strong cash position of $499.2 million.

•2mo ago

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy

The FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk of disease progression. The approval is based on the Phase 3 ORIGIN 3 trial, where TRUTAKNA achieved a statistically and clinically meaningful 42% reduction in proteinuria compared to placebo at 36 weeks. This marks the company's transition to a commercial-stage entity, with confirmatory trial results regarding kidney function decline (eGFR) anticipated in Q3 2026.

•3mo ago

Vera Therapeutics Announces Alignment with U.S. FDA on Earlier ORIGIN Phase 3 Analysis to Support Potential Full Approval for Atacicept in Adults with IgA Nephropathy

Vera Therapeutics has aligned with the FDA on an accelerated development plan for its lead asset atacicept in IgA Nephropathy (IgAN). The pivotal ORIGIN Phase 3 eGFR analysis has been pulled forward from 2027 to Q3 2026, supporting a supplemental BLA submission in Q4 2026 and a PDUFA date for accelerated approval on July 7, 2026. This timeline acceleration follows positive Phase 2b data and a recent National Kidney Foundation workshop, positioning atacicept as a potential first-in-class therapy targeting both BAFF and APRIL.

•4mo ago

Vera Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

Vera Therapeutics announced that the FDA granted Priority Review to the BLA for atacicept for the treatment of IgA Nephropathy, with a target PDUFA action date of July 7, 2026. The company is on track for a potential U.S. commercial launch of atacicept in mid-2026, pending regulatory approval, and reported a strong balance sheet with nearly $597M in cash and equivalents to fund operations beyond launch. For the first quarter, Vera reported a net loss of $121.0 million, or $1.69 per share, driven by increased R&D and G&A expenses as the company prepares for commercialization.

•5mo ago