Earnings summaries and quarterly performance for Vera Therapeutics.
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Vera Therapeutics Provides Update on Atakicept Phase III Data, BLA Filing, and Commercial Readiness
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera Therapeutics (VERA) announced positive and compelling Phase III data for its lead product candidate, Atakicept, in IgAN nephropathy, with the BLA filing submitted on November 7 and a potential PDUFA date in July. Atakicept has breakthrough designation.
- The company is well-resourced for the upcoming launch, ending the year with $400 million-$500 million and access to an additional $500 million through a facility with Oxford, providing approximately $1 billion for the first launch year.
- Atakicept is positioned as a differentiated therapy, being the first dual BAF-APRL inhibitor and the only program approaching launch with an autoinjector for patient convenience. Its safety profile is similar to placebo.
- Vera is also advancing its pipeline, including a monthly dosing study for Atakicept with early data expected in 2026, and the acquired VT109, a new molecule with potential for quarterly dosing, with an IND filing as the next catalyst.
1 day ago
Vera Provides Update on Atakicept Regulatory Filing and Launch Preparations
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera's lead product candidate, Atakicept, for IgA nephropathy (iGAN), has shown positive Phase 3 data, and a Biologics License Application (BLA) was filed on November 7.
- The company expects to hear about a PDUFA date announcement in early January, with a potential PDUFA date in July.
- Atakicept is anticipated to launch with an autoinjector and is positioned as the first dual BAF-APRL inhibitor in the iGAN market, which has an estimated 160,000 biopsy-confirmed cases in the United States.
- Vera is well-capitalized for the upcoming launch, ending the year (FY 2025) with $400 million-$500 million and access to an additional $500 million through a facility, providing roughly $1 billion for the first launch year.
1 day ago
Vera Therapeutics Submits BLA for Atakicept in IgA Nephropathy and Prepares for Launch
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics submitted its Biologics License Application (BLA) for Atakicept in IgA nephropathy (iGAN) on November 7, following positive Phase 3 data and breakthrough designation, anticipating a PDUFA date in July and a launch with an autoinjector.
- Atakicept, a dual BAF-APRL inhibitor, has demonstrated two-year kidney function data by estimated GFR and a safety profile similar to placebo, targeting a US patient population of approximately 160,000 biopsy-confirmed cases.
- The company is well-capitalized with an estimated $400 million-$500 million ending the year and access to an additional $500 million, providing approximately $1 billion for the launch next year.
- Vera is also expanding its pipeline by studying Atakicept in other autoimmune kidney diseases and developing VT109, a new molecule for potential quarterly dosing.
1 day ago
Vera Therapeutics Files BLA for Atacicept, Prepares for 2026 Launch
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera Therapeutics filed its Biologics License Application (BLA) for atacicept in IgA nephropathy on November 7, 2025, anticipating potential approval in mid-2026 with priority review.
- The company is prepared for a U.S. commercial launch in 2026, having established its commercial leadership team and sales force structure.
- Atacicept demonstrated two-year eGFR stability with a slope of minus 0.6, comparable safety to placebo, and no evidence of neutralizing antidrug antibodies or infection-associated hypogammaglobulinemia in phase 2 and 3 trials. It is also designed for a low-volume autoinjector.
- Vera is exploring additional indications through its PIONEER phase 2 trial for broader IgA nephropathy and other autoimmune glomerular diseases, and has initiated a study for monthly atacicept dosing. The company sees potential for 11+ additional indications beyond nephrology, targeting a double-digit billion-dollar market.
3 days ago
Vera Therapeutics Provides Update on Atacicept Phase 3 Results, BLA Filing, and Commercial Launch Plans
VERA
Product Launch
Guidance Update
New Projects/Investments
- Vera Therapeutics announced the readout of Phase 3 results for atacicept in IgA nephropathy in November 2025, with simultaneous publication in the New England Journal of Medicine.
- The company filed its Biologics License Application (BLA) for atacicept on November 7, 2025, anticipating a potential approval in mid-2026 and preparing for a US commercial launch in 2026.
- Atacicept is highlighted as a best-in-class molecule, demonstrating two-year eGFR stability (slope of GFR of minus 0.6) and safety comparable to placebo, with a planned low-volume autoinjector.
- Vera is conducting the PIONEER phase 2 trial for atacicept in a broader IgA nephropathy patient population and other autoimmune glomerular diseases, with an update expected in Q4 2025 or early 2026.
- The company is also developing a monthly dosing regimen for atacicept and a long-acting BAFF APRIL inhibitor, VT109, targeting every three to six months dosing, with an estimated double-digit billion-dollar market potential across at least 11 additional indications.
3 days ago
Vera Therapeutics Provides Update on Atacicept Phase 3 Results, BLA Filing, and 2026 Commercial Launch Plans
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera Therapeutics presented positive Phase 3 results for atacicept in IgA nephropathy in November 2025, with simultaneous publication in the New England Journal of Medicine.
- The company filed its Biologics License Application (BLA) for atacicept on November 7, 2025, anticipating priority review and a potential U.S. approval in mid-2026.
- Vera is preparing for the U.S. commercial launch of atacicept in 2026, highlighting its "best-in-class" profile with two-year eGFR stability, safety comparable to placebo, and a convenient low-volume autoinjector.
- The PIONEER Phase 2 trial is exploring atacicept in broader IgA nephropathy and other autoimmune glomerular diseases, with an update anticipated in 2026.
- The company also aims to develop a monthly dosing regimen for atacicept and a new long-acting product, VT-109, targeting a double-digit billion-dollar market potential across multiple indications.
3 days ago
Vera Therapeutics Presents Atacicept Phase 3 Results and BLA Filing
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera Therapeutics presented positive Phase 3 results for atacicept in IgA nephropathy (IgAN) at the ASN conference, demonstrating a 42% placebo-adjusted reduction in proteinuria which surpasses the FDA's 30% threshold for accelerated approval.
- Following the presentation, Vera Therapeutics announced the filing of its Biologics License Application (BLA) for atacicept, aiming to bring the medicine to patients next year.
- The Phase 2b program showed long-term GFR stability, with an annual rate of loss of -0.6 mL per minute over two years, comparable to a healthy population.
- Atacicept exhibited a favorable safety profile across Phase 2 and Phase 3 studies, with no increased risk of infection or hypogammaglobulinemia observed at the 150 mg weekly dose.
- The company is also progressing with the Pioneer Basket study, a Phase 2 program evaluating atacicept in a broader IgAN patient cohort and other autoimmune kidney diseases, with initial data anticipated this quarter.
Nov 13, 2025, 6:30 PM
Vera Therapeutics Submits BLA for Atacicept for IgAN
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics has submitted a Biologics License Application (BLA) to the U.S. FDA for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN) through the Accelerated Approval Program.
- The BLA is supported by data from the ORIGIN 3 Phase 3 trial, which demonstrated atacicept achieved a 46% reduction from baseline in proteinuria and a 42% reduction compared to placebo at week 36.
- Atacicept has received FDA Breakthrough Therapy Designation for IgAN and, if approved, would be the first B cell modulator targeting both BAFF and APRIL for this condition, with potential FDA approval in 2026.
Nov 7, 2025, 11:27 PM
Vera Therapeutics Highlights Atacicept's Positive Phase 3 Results and 2026 US Launch Projection
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics, a biotechnology company founded in 2016, is developing atacicept, a potential first-in-class dual BAFF/APRIL inhibitor for autoimmune diseases, which has shown positive Phase 3 results for IgA Nephropathy (IgAN).
- The company plans to submit a Biologics License Application (BLA) for atacicept in Q4 2025, with a projected US market launch in 2026, subject to FDA approval.
- Clinical trials (ORIGIN Phase 2b and Phase 3) demonstrated atacicept's efficacy in reducing proteinuria, Gd-IgA1, and hematuria, and stabilizing eGFR, with a favorable safety profile comparable to placebo.
- The US IgAN market is estimated to reach approximately 160,000 patients by 2032, presenting a significant commercial opportunity for atacicept, which is positioned for high-risk patients and has potential for premium pricing.
Nov 6, 2025, 9:30 PM
Vera Announces Positive Atacicept Phase III Interim Results and 2026 Commercial Launch Plans
VERA
Product Launch
New Projects/Investments
Guidance Update
- Vera announced positive interim results from the ORIGIN phase III trial of atacicept for IgA nephropathy, demonstrating a 46% reduction in proteinuria at 36 weeks compared to a 7% reduction in placebo, with a safety profile comparable to placebo.
- The company is on track to file its Biologics License Application (BLA) this quarter (Q4 2025), with a potential U.S. commercial launch anticipated in mid-2026.
- Vera reported a strong financial position with pro forma cash of $497 million and access to an additional $425 million in non-dilutive capital, which is expected to fund the company through multiple catalysts, including approval and launch.
- Atacicept, a potential first-in-class dual-BAFF APRIL inhibitor, targets an addressable U.S. market of 90,000 IgA nephropathy patients.
- Vera is also expanding its pipeline with additional clinical trials for atacicept (EXTEND and PIONEER) in other autoimmune kidney diseases, and advancing MAU868 and VT109.
Nov 6, 2025, 9:30 PM
Quarterly earnings call transcripts for Vera Therapeutics.
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