FDA Fast-Tracks Vera's At-Home Kidney Drug

Vera Therapeutics Inc. (NASDAQ:VERA) stock rose Wednesday after the U.S. Food and Drug Administration (FDA) accepted the company’s atacicept Biologics License Application (BLA) for Priority Review.

The application covers adults with immunoglobulin A nephropathy (IgAN).

IgAN is an autoimmune disease of the kidney. In at least 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure.

Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases.

Regulatory Timeline and Approval Pathway

The BLA, which was submitted using the Accelerated Approval Program, was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026.

If approved, atacicept could offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.

The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36.

Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo at week 36.

Analyst Commentary

In October 2025, Bank of America Securities analyst Dina Ramadane said, “We view potential for upside in VERA shares coming from its lead drug, atacicept, launching into a multi-billion-dollar market which we expect to beat consensus and quell concerns about competitive risk.”

Analyst Ramadane said the $3 billion nominal peak sales forecast (2037e) reflects that atacicept could offer a favorable treatment option in multiple autoimmune disorders, pending future clinical data validation.

Competitive Landscape

In October 2025, Novartis A/S (NYSE:NVS) shared final results from the APPLAUSE-IgAN Phase 3 study of Fabhalta (iptacopan) in adults with IgAN.

Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate decline over two years. 

VERA Price Action: Vera Therapeutics shares were up 4.49% at $48.61 at the time of publication on Wednesday, according to Benzinga Pro data.

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