Vera Therapeutics Inc. (VERA) shares jumped Wednesday after landing a crucial regulatory milestone: the FDA accepted its application for atacicept and granted it priority review status. This designation typically shaves four months off the review process, which matters quite a bit when you're racing to reach patients with a serious disease.

The drug targets immunoglobulin A nephropathy, or IgAN, an autoimmune disease that attacks the kidneys. Here's why that matters: in at least half of patients, IgAN eventually progresses to end-stage kidney disease or outright kidney failure. That's the kind of outcome that transforms lives in terrible ways.

Atacicept works by blocking two cytokines called BAFF and APRIL, which sound like characters from a children's book but actually drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases. The interesting part? It's designed as a once-weekly subcutaneous injection that patients can self-administer at home using an autoinjector. No infusion centers, no clinic visits for the injection itself.

What the Timeline Looks Like

Vera submitted the Biologics License Application through the Accelerated Approval Program, and the FDA assigned a target decision date of July 7, 2026, under the Prescription Drug User Fee Act. That's the date circled on every calendar at Vera's headquarters.

The application leans on data from a prespecified interim analysis of the ORIGIN 3 trial, which hit its primary endpoint at week 36. Patients treated with atacicept saw their proteinuria drop 46% from baseline, measured by 24-hour urine protein-to-creatinine ratio. Compared to placebo, the reduction was 42%, and both the statistical significance and clinical meaningfulness boxes got checked.

Proteinuria, for context, means excess protein spilling into urine because the kidneys aren't filtering properly. Reducing it suggests the kidneys are working better, which is exactly what you want to see in a kidney disease trial.

The Market Opportunity

Back in October 2025, Bank of America Securities analyst Dina Ramadane initiated coverage with an optimistic take: "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."

Ramadane's $3 billion peak sales forecast for 2037 reflects something bigger than just IgAN. The analyst believes atacicept could work across multiple autoimmune disorders, assuming future clinical data validates that broader potential. That's speculative but not unreasonable given the drug's mechanism.

Competition on the Horizon

Novartis A/S (NVS) isn't sitting idle. The pharmaceutical giant released final Phase 3 results for Fabhalta (iptacopan) in adults with IgAN back in October 2025. Fabhalta demonstrated statistically significant superiority over placebo in slowing disease progression, measured by the annualized total slope of estimated glomerular filtration rate decline over two years.

That's a different endpoint than what Vera measured in its interim analysis, but it speaks to kidney function preservation, which is ultimately what regulators and doctors care about. The IgAN treatment landscape is getting crowded, and both companies are positioning for what could be a substantial market.

Vera Therapeutics shares closed up 4.49% at $48.61 on Wednesday following the FDA announcement.