Vera reports Q3 2026 results as TRUTAKNA launch builds and sBLA filed for full approval

Vera Therapeutics reported third quarter 2026 results on November 5, 2026, highlighting early uptake of TRUTAKNA (atacicept-vymj) after the FDA granted accelerated approval on July 7, 2026 to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The company said the U.S. launch has generated roughly 700 Patient Start Forms to date along with $10.3 million of net product revenue in the quarter.¹

At ASN Kidney Week 2026, Vera presented final efficacy data from the "ORIGIN 3" trial as a late-breaking oral presentation during the opening plenary session, with simultaneous publication in The New England Journal of Medicine. The company reported that TRUTAKNA met all prespecified endpoints, including eGFR change from baseline and annualized slope, and risk reduction in composite kidney disease progression events, with an annualized eGFR slope through 104 weeks of -0.6 mL/min/1.73m² per year versus -5.6 for placebo, a treatment difference of 5.0 mL/min/1.73m² per year (p<0.0001), and a safety profile generally comparable to placebo.¹

Based on those results, Vera completed a supplemental Biologics License Application submission to the FDA on November 3, 2026, seeking full approval of TRUTAKNA in adults with primary IgAN.¹ The company said potential full approval is expected in mid-2027, subject to FDA review of the sBLA,¹ and it also plans to submit a Marketing Authorisation Application to the European Medicines Agency in the first quarter of 2027 for standard marketing authorisation.¹

On the balance sheet, Vera held $384.0 million in cash, cash equivalents, and marketable securities as of September 30, 2026; it drew $75 million under its debt facility in late October, which on a pro forma basis would bring the total to $459 million, with up to $350 million still available under the facility subject to certain conditions.¹