Vera Therapeutics secures FDA alignment to accelerate the Phase 3 ORIGIN eGFR readout of atacicept in IgA nephropathy to Q3 2026. Positive results could support a supplemental BLA later this year and full approval in 2027.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Vera Therapeutics has secured FDA agreement on a revised analysis plan for the Phase 3 ORIGIN trial (NCT04716231) of atacicept in Immunoglobulin A Nephropathy (IgAN). The revised plan advances the pivotal kidney function readout into the third quarter of 2026, potentially accelerating the path to full approval.
The company is also awaiting a July 7, 2026 Prescription Drug User Fee Act (PDUFA) decision on its Biologics License Application (BLA) seeking accelerated approval of atacicept based on proteinuria reduction data from the ORIGIN program. Pending positive eGFR results, Vera intends to submit a supplemental BLA (sBLA) in the fourth quarter of 2026.
Mechanism of Action
Atacicept is a soluble recombinant fusion protein containing the native human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor. The therapy simultaneously inhibits B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), two cytokines that drive B-cell survival and autoantibody production.
By targeting both pathways, atacicept reduces immune-mediated kidney injury associated with IgAN, the most common form of primary glomerulonephritis worldwide and a leading cause of chronic kidney disease and kidney failure.
Clinical Evidence Across the ORIGIN Program
The FDA alignment follows discussions within the nephrology community, including a National Kidney Foundation workshop involving clinicians, researchers, regulators, and patient advocates. The decision was also supported by kidney function findings from the Phase 2b ORIGIN trial.
In the Phase 2b study, atacicept met its primary and key secondary endpoints, producing statistically significant reductions in proteinuria and stabilization of eGFR compared with placebo through 36 weeks. Longer-term follow-up through 96 weeks showed sustained improvements in galactose-deficient IgA1 (Gd-IgA1), hematuria, and proteinuria, alongside continued stabilization of kidney function.
In the ongoing Phase 3 ORIGIN trial, atacicept achieved the primary endpoint in a prespecified interim analysis. The therapy demonstrated a 46% reduction in proteinuria from baseline and a 42% reduction versus placebo at week 36 (p<0.0001). The safety profile remained comparable to placebo across the ORIGIN program.
The trial continues in a blinded, placebo-controlled manner to evaluate long-term kidney function outcomes as measured by eGFR, with results now expected in Q3 2026.
Clinical Implications
Marshall Fordyce, MD, founder and chief executive officer of Vera Therapeutics, said the revised timeline could accelerate delivery of the first approved therapy targeting both BAFF and APRIL in adults with IgAN. He noted that advancing the eGFR analysis may support an earlier path to full regulatory approval.
Expanding Development Beyond IgAN
Vera continues to broaden atacicept’s clinical development program beyond IgAN. The therapy is currently being evaluated in anti-PLA2R-positive primary membranous nephropathy, as well as anti-nephrin-positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) through the PIONEER trial.
The company has also completed enrollment in a monthly dose-ranging study evaluating the effectiveness, safety, and tolerability of alternative atacicept dosing regimens.
With a PDUFA decision expected in July and pivotal kidney function data anticipated later in 2026, Vera faces two major regulatory catalysts that could shape atacicept’s approval pathway and commercial launch trajectory over the next year.
References
About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.