FDA Expedites Approval of Vera’s Home-Based Kidney Medication

Vera Therapeutics Gains on FDA Priority Review for Atacicept

Shares of Vera Therapeutics Inc (NASDAQ: VERA) climbed on Wednesday after the U.S. Food and Drug Administration (FDA) agreed to review the company’s Biologics License Application (BLA) for atacicept under its Priority Review process.

This application seeks approval for the treatment of adults diagnosed with immunoglobulin A nephropathy (IgAN).

Understanding IgAN and Atacicept

IgAN is a kidney disorder driven by autoimmune activity. For at least half of those affected, the disease can progress to advanced kidney disease or complete kidney failure.

Atacicept is being developed as a once-weekly, self-injected subcutaneous therapy for home use. The drug works by blocking B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL)—two cytokines that promote the production of autoantibodies by B-cells, which are linked to IgAN and other autoimmune kidney conditions.

Regulatory Milestones and Approval Process

The BLA for atacicept was submitted through the FDA’s Accelerated Approval Program. The Prescription Drug User Fee Act (PDUFA) has set a target decision date of July 7, 2026.

If the FDA grants approval, patients could have access to an autoinjector for convenient, at-home administration of atacicept once per week.

The submission is backed by interim results from the ORIGIN 3 clinical trial, which achieved its main goal of reducing proteinuria at 36 weeks.

Patients receiving atacicept saw proteinuria levels drop by 46% from baseline, as measured by the 24-hour urine protein-to-creatinine ratio (UPCR). Compared to placebo, there was a statistically significant and clinically meaningful 42% reduction in UPCR at week 36.

Analyst Insights

In October 2025, Dina Ramadane, an analyst at Bank of America Securities, commented that Vera’s lead candidate, atacicept, could drive significant growth for the company as it enters a multi-billion-dollar market. Ramadane expects the drug to outperform consensus forecasts and alleviate concerns about competition.

The analyst’s projection for atacicept’s peak annual sales is $3 billion by 2037, reflecting its potential to become a preferred therapy for several autoimmune diseases, pending further clinical validation.

Competitive Environment

Also in October 2025, Novartis AG (NYSE: NVS) released final data from its Phase 3 APPLAUSE-IgAN study of Fabhalta (iptacopan) in adults with IgAN.

Fabhalta demonstrated a significant and clinically important advantage over placebo in slowing the progression of IgAN, as measured by the annualized decline in estimated glomerular filtration rate over a two-year period.

Stock Performance

VERA Stock Update: Vera Therapeutics shares were trading 4.49% higher at $48.61 as of Wednesday, according to Benzinga Pro data.

Image credit: Tada Images via Shutterstock

Stock Snapshot

• VERA – Vera Therapeutics Inc
  Price: $48.35
  Change: +3.94%
• NVS – Novartis AG
  Price: $142.31
  Change: +0.03%