Investors Await Key Regulatory Milestone
Vera Therapeutics (NASDAQ:VERA) shares gained 6% on Monday as investors positioned ahead of the U.S. Food and Drug Administration’s Prescription Drug User Fee Act (PDUFA) decision on atacicept for the treatment of adults with Immunoglobulin A Nephropathy (IgAN), scheduled for 7 July.
The FDA is reviewing the company’s Biologics License Application (BLA), which seeks accelerated approval for the investigational therapy.
Atacicept Targets Two Immune Pathways
Atacicept is an investigational soluble recombinant fusion protein designed to inhibit both B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), two cytokines involved in B-cell survival and the production of autoantibodies associated with IgA Nephropathy.
The dual-target approach is intended to address the underlying immune mechanisms that contribute to disease progression.
Phase 3 Programme Continues to Advance
In June, Vera Therapeutics announced that it had reached agreement with the FDA on a revised analysis plan for estimated glomerular filtration rate (eGFR) data from the ORIGIN 3 study.
Results are now expected during the third quarter of 2026, earlier than the previously anticipated 2027 timeline.
If the eGFR findings are positive, the company plans to submit a supplemental Biologics License Application (sBLA) in the fourth quarter of 2026, which could support full FDA approval in 2027.
Clinical Results Support Regulatory Filing
The Phase 3 ORIGIN trial achieved its primary endpoint by demonstrating a statistically significant reduction in proteinuria at Week 36 during the pre-specified interim analysis.
The earlier Phase 2b ORIGIN study also met both its primary and key secondary endpoints, showing reductions in proteinuria and stabilization of eGFR compared with placebo through 36 weeks.
Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgA Nephropathy and has been administered to more than 1,500 patients across clinical studies in multiple disease indications.