Company Description
Vera Therapeutics, Inc. (Nasdaq: VERA) is a late clinical-stage biotechnology company focused on developing treatments for serious immunological and autoimmune diseases. The company describes its mission as advancing treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ work centers on B-cell biology and autoantibody-driven conditions, with programs that address kidney and transplant-related diseases where unmet medical need remains high.
The company’s lead product candidate is atacicept, an investigational recombinant fusion protein self-administered at home as a once-weekly subcutaneous injection. Atacicept blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that stimulate B cells and plasma cells to produce autoantibodies associated with certain autoimmune diseases. Vera Therapeutics is developing atacicept for immunoglobulin A nephropathy (IgAN), a serious and progressive autoimmune kidney disease, and is also evaluating its potential in lupus nephritis and other autoimmune kidney diseases.
According to company disclosures, atacicept has received U.S. FDA Breakthrough Therapy Designation for the treatment of IgAN. Vera Therapeutics submitted a Biologics License Application (BLA) for atacicept for adults with IgAN through the FDA’s Accelerated Approval Program, and the FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN, and could be offered as an autoinjector for at-home self-administration.
The atacicept clinical program in IgAN includes the ORIGIN Phase 2b trial and the ongoing ORIGIN 3 Phase 3 trial. Company reports state that ORIGIN Phase 2b met its primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in proteinuria and stabilization of estimated glomerular filtration rate (eGFR) versus placebo through 36 weeks, with further improvements in Gd-IgA1, hematuria, and proteinuria through 96 weeks. ORIGIN 3 is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial in adults with IgAN. A prespecified 36-week interim analysis met the primary endpoint of reduction in proteinuria, with a reported 46% reduction from baseline and a 42% reduction versus placebo in 24-hour urine protein-to-creatinine ratio. Across the ORIGIN program, the safety profile of atacicept is described as favorable and comparable to placebo.
Beyond the core IgAN program, Vera Therapeutics is evaluating atacicept in additional settings where reduction of autoantibodies may be clinically meaningful. These include expanded IgAN populations and other autoimmune kidney diseases such as anti-PLA2R positive primary membranous nephropathy and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD), as described in the company’s PIONEER trial. The ORIGIN Extend study provides extended access to atacicept for ORIGIN participants and is designed to capture longer-term safety and efficacy data until potential commercial availability in relevant regions.
Vera Therapeutics also holds an exclusive license agreement with Stanford University for VT-109, described as a novel, next-generation fusion protein targeting BAFF and APRIL. The company characterizes VT-109 as having wide therapeutic potential across the spectrum of B-cell–mediated diseases, reflecting a broader strategic focus on B-cell and autoantibody pathways beyond a single indication. VT-109 remains an investigational asset within Vera Therapeutics’ pipeline.
In addition to its BAFF/APRIL-targeting programs, Vera Therapeutics is developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus. BK virus infection can have serious consequences in kidney transplant recipients, and Vera Therapeutics’ disclosures emphasize the potential impact of an effective neutralizing antibody in this setting. The company states that it retains all global developmental and commercial rights to atacicept, VT-109, and MAU868.
Vera Therapeutics is based in Brisbane, California, and its Class A common stock trades on The Nasdaq Stock Market LLC under the symbol VERA, as indicated in its SEC filings. As a late clinical-stage biotechnology issuer, the company regularly uses public offerings and at-the-market sales agreements to support its development activities, as reflected in its Form 8-K filings describing underwritten offerings of Class A common stock and a sales agreement with TD Securities (USA) LLC. These filings also highlight the company’s use of inducement equity awards under a 2024 Inducement Plan to attract new employees, consistent with Nasdaq Listing Rule 5635(c)(4).
Vera Therapeutics communicates clinical and regulatory milestones through press releases and SEC reports, including data presentations at major medical meetings such as the American Society of Nephrology Kidney Week and publications in peer-reviewed journals such as The New England Journal of Medicine. The company also participates in healthcare and investor conferences, where its management team presents updates on the atacicept program, broader pipeline, and corporate strategy.
Business focus and development model
Vera Therapeutics describes itself as a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases. Its development model centers on:
- Targeting the source of disease by modulating B-cell activity and autoantibody production through BAFF and APRIL inhibition.
- Advancing atacicept through Phase 2b and Phase 3 clinical programs in IgAN and other autoimmune kidney diseases.
- Building a pipeline of B-cell–focused biologics, including VT-109 under an exclusive license from Stanford University.
- Developing MAU868 to address BK virus infection in kidney transplant recipients.
- Maintaining global developmental and commercial rights to its key product candidates.
Through these activities, Vera Therapeutics positions itself within the biotechnology sector as a company concentrating on immunology and nephrology, with an emphasis on autoantibody-driven disease mechanisms.
Key programs and indications
- Atacicept in IgA nephropathy (IgAN): Investigational fusion protein targeting BAFF and APRIL, developed as a once-weekly subcutaneous injection for at-home self-administration. Supported by Phase 2b and Phase 3 ORIGIN trial data, with a BLA under Priority Review by the U.S. FDA for adults with IgAN.
- Atacicept in other autoimmune kidney diseases: Evaluation in expanded IgAN populations and conditions such as lupus nephritis, primary membranous nephropathy, FSGS, and MCD, where autoantibody reduction may be clinically relevant.
- VT-109: Next-generation BAFF/APRIL-targeting fusion protein licensed from Stanford University, with stated potential across B-cell–mediated diseases.
- MAU868: Monoclonal antibody designed to neutralize BK virus infection, which can have serious consequences in kidney transplant recipients.
Regulatory and clinical milestones
From the information provided, notable milestones for Vera Therapeutics and atacicept include:
- FDA Breakthrough Therapy Designation for atacicept in IgAN.
- Submission of a BLA for atacicept for adults with IgAN via the Accelerated Approval Program.
- FDA Priority Review of the BLA with a specified PDUFA target action date.
- Positive interim results from the ORIGIN 3 Phase 3 trial in IgAN, with statistically significant and clinically meaningful reductions in proteinuria and a safety profile described as comparable to placebo.
- Presentation of ORIGIN Phase 3 data at the American Society of Nephrology Kidney Week and simultaneous publication in The New England Journal of Medicine.
Stock and corporate governance
Vera Therapeutics’ Class A common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and listed on The Nasdaq Stock Market LLC under the symbol VERA, as reflected in multiple Form 8-K filings. The company’s board of directors oversees corporate governance, including the appointment of directors and committee members. For example, an 8-K dated November 26, 2025 reports the appointment of James R. Meyers as a Class II director and member of the Audit Committee, along with related equity compensation under the company’s non-employee director compensation policy.
Vera Therapeutics also reports changes in executive roles and material agreements through its SEC filings. An 8-K dated December 16, 2025 notes that the company’s Chief Legal Officer will no longer serve in that role as of December 24, 2025. Another 8-K dated August 5, 2025 describes entry into a Sales Agreement with TD Securities (USA) LLC for potential at-the-market offerings of Class A common stock, replacing a prior sales agreement.
Location and regulatory reporting
SEC filings list Vera Therapeutics’ principal offices in Brisbane, California. The company files current reports on Form 8-K to disclose material events such as clinical data announcements, financing transactions, sales agreements, and changes in directors or officers. These filings, together with press releases, provide investors with ongoing information about the company’s development programs and corporate activities.