Vera's Atacicept on Fast Track for Kidney Disease Approval

BRISBANE, CA – January 07, 2026 – Vera Therapeutics received a significant boost in its mission to treat a debilitating autoimmune kidney disease, as the U.S. Food and Drug Administration (FDA) granted Priority Review for its Biologics License Application (BLA) for atacicept. The drug, aimed at adults with immunoglobulin A nephropathy (IgAN), is now on a fast track for a potential approval decision, with the FDA setting a target action date of July 7, 2026.

The designation signals the agency's belief that atacicept could represent a major advance in treating IgAN, a serious condition with limited therapeutic options. If approved, atacicept would become the first B cell modulator to target two distinct drivers of the disease, BAFF and APRIL, offering a novel approach for patients.

"Atacicept offers a distinct approach through dual targeting of BAFF and APRIL, which we believe could advance the standard of care in IgAN, if approved,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, in a statement. “FDA’s Priority Review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape."

The Silent Progression of IgA Nephropathy

IgA nephropathy, also known as Berger's disease, is the world's most common form of glomerulonephritis, an inflammatory condition of the kidney's filtering units. It is a progressive autoimmune disease where the body's own immune system mistakenly produces harmful IgA autoantibodies. These antibodies form immune complexes that get trapped in the kidneys, triggering inflammation and scarring that gradually destroys kidney function.

For many, the disease progresses silently for years. However, its consequences are severe. Up to half of all patients with IgAN will eventually develop end-stage kidney disease, requiring life-sustaining dialysis or a kidney transplant. The journey to diagnosis is often fraught with delays, with studies showing nearly half of patients are misdiagnosed or face significant waits for a correct diagnosis, losing precious time to preserve kidney function.

The current standard of care has historically focused on supportive measures, such as blood pressure control with RAAS inhibitors and, more recently, SGLT2 inhibitors. While several targeted therapies have gained approval in recent years—including Tarpeyo, Filspari, and Fabhalta—they address different aspects of the disease pathway. Many nephrologists believe a significant unmet need remains for treatments that can halt or reverse the disease's underlying cause and achieve more substantial reductions in proteinuria, a key marker of kidney damage and disease progression.

A Dual-Action Approach with Promising Results

Atacicept stands apart with its unique mechanism of action. It is a recombinant fusion protein designed to simultaneously inhibit B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL). These two cytokines are critical for the survival of B-cells and plasma cells that produce the pathogenic autoantibodies at the root of IgAN. By blocking both, atacicept aims to strike at the source of the disease.

The BLA submission is anchored by compelling data from the Phase 3 ORIGIN 3 trial. A prespecified interim analysis at 36 weeks showed that patients treated with atacicept achieved a statistically significant and clinically meaningful 46% reduction in proteinuria from baseline. This translated to a 42% greater reduction compared to patients receiving a placebo, a result so significant it was published in the New England Journal of Medicine.

Furthermore, the safety profile of atacicept in clinical trials has been favorable and comparable to placebo. Another major advantage is its proposed administration: a once-weekly subcutaneous injection that patients can self-administer at home with an autoinjector. This convenience could dramatically improve quality of life and treatment adherence compared to therapies requiring clinical visits for infusion.

Navigating a Strategic Regulatory Path

Vera Therapeutics' journey with atacicept showcases a savvy navigation of the FDA's expedited regulatory pathways. The drug had previously received Breakthrough Therapy Designation, an honor reserved for treatments that may demonstrate substantial improvement over available therapies for serious conditions. This was based on earlier data from the Phase 2b ORIGIN trial.

The company submitted its BLA through the Accelerated Approval Program, which allows for earlier approval of drugs for serious conditions based on a surrogate endpoint—in this case, proteinuria reduction—that is reasonably likely to predict a long-term clinical benefit. The granting of Priority Review now shortens the FDA's review timeline from the standard ten months to just six, underscoring the agency's recognition of the urgent need for new IgAN treatments.

As a condition of the accelerated pathway, Vera is continuing the ORIGIN 3 trial in a blinded fashion. The study's full two-year results, expected in 2027, will evaluate the drug's long-term impact on estimated glomerular filtration rate (eGFR), a direct measure of kidney function. These confirmatory results will be crucial to securing full approval and cementing atacicept's place in the treatment paradigm.

A Competitive Market with High Stakes

The potential approval of atacicept would launch it into an increasingly competitive but lucrative market. The global IgAN market is valued in the billions of dollars, attracting intense interest from biotechnology and pharmaceutical companies. Vera will be competing with recently approved therapies from Travere Therapeutics (Filspari) and Novartis (Fabhalta), each with a different mechanism of action.

The pipeline is also robust. Novartis is advancing its own anti-APRIL monoclonal antibody, zigakibart, with Phase 3 results expected in 2026. Other companies are exploring different targets, from plasma cells to other complement pathways.

In this crowded field, atacicept's dual BAFF/APRIL inhibition, strong proteinuria reduction data, and convenient at-home administration are key differentiators. Investors have taken note of this potential. Vera's stock (Nasdaq: VERA) rose over 4% on the news and has seen significant gains in recent months. While the company is still a clinical-stage biotech with no revenue, analysts see atacicept as a powerful growth driver. Some valuation models suggest the company's stock may still be undervalued relative to the drug's market potential, though it carries the inherent risks of a company awaiting its first product approval.

With a PDUFA date set for this summer, the next six months will be critical for Vera Therapeutics. A positive FDA decision would not only be a transformative event for the company but would also deliver a promising new weapon to physicians and patients in the ongoing fight against IgA nephropathy.