Core Insights - Vera Therapeutics has appointed Matt Skelton as Chief Commercial Officer to lead the commercial launch of atacicept for IgA nephropathy [1][2] - Atacicept is a promising investigational treatment that targets B-cell activation and has shown significant clinical efficacy in trials [3][4][6] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [10] - The company's lead product candidate, atacicept, is designed to block B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases [10] Leadership Appointment - Matt Skelton brings extensive experience in global commercialization, having previously scaled Seagen's commercial organization from one product to four approved products [2][10] - His leadership is expected to be critical in transitioning Vera Therapeutics into a commercial-stage company [2] Atacicept Clinical Program - The ORIGIN Phase 2b clinical trial of atacicept met its primary and key secondary endpoints, showing significant reductions in proteinuria and stabilization of eGFR [4] - The ongoing ORIGIN 3 Phase 3 trial has also met its primary endpoint with a statistically significant reduction in proteinuria at week 36 [5] Regulatory Status - Atacicept has received Breakthrough Therapy Designation from the FDA for IgA nephropathy, indicating its potential to significantly improve treatment outcomes [6] - The Biologics License Application (BLA) for atacicept has received Priority Review designation, with a target action date set for July 7, 2026 [7] Future Studies - The ORIGIN Extend study allows participants to access atacicept until its commercial availability and collects long-term safety and efficacy data [8] - Atacicept is also being evaluated in other autoimmune kidney diseases, expanding its potential therapeutic applications [8][10]

Company Overview - Vera Therapeutics was founded in San Francisco in 2016 and in-licensed atacicept in 2020 [3] - The company aims to lead a paradigm shift in modulating the immune system to alleviate disease burdens [1] Product Information - Atacicept is a first-in-class dual BAFF April inhibitor, designed to control autoimmune disease activity while minimizing immune suppression challenges [3] - Positive Phase III results were reported last year, leading to the submission of a Biologics License Application (BLA) to the U.S. FDA [3] - The FDA has awarded priority review for atacicept, with a Prescription Drug User Fee Act (PDUFA) date set for July 7, 2026 [3]

Summary of Vera Therapeutics FY Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Founded**: 2016 in San Francisco - **Lead Product**: Atacicept, a first-in-class dual BAFF/APRIL inhibitor - **Financial Position**: Pro forma cash of $779 million with 71.3 million shares outstanding [4][5] Industry Context - **Primary Indication**: IgA nephropathy (IgAN), the most common primary glomerular disease worldwide, with an incidence of 2.5 per 100,000 people [6] - **Market Size**: Estimated 160,000 diagnosed IgAN patients in the U.S., with half in the highest-risk category [14] - **Competitive Landscape**: Five new drugs approved for IgAN in the past five years, indicating a growing market with premium pricing [16] Key Product Insights - **Atacicept Mechanism**: Targets BAFF and APRIL to modulate B-cell function, potentially avoiding immune suppression challenges [3][5] - **Clinical Trials**: - Phase III trial met primary endpoint with a 42% placebo-adjusted reduction in proteinuria at 36 weeks [11] - Secondary endpoints showed consistent results with phase II data [11] - Ongoing trials include PIONEER, studying Atacicept in moderate and low-risk patients [15] Regulatory and Commercialization Plans - **BLA Submission**: Submitted to the U.S. FDA with priority review status; PDUFA date set for July 7, 2026 [3][18] - **Commercial Launch**: Expected in July 2026, with a focus on educating nephrologists about Atacicept [13][21] - **Sales Force**: Hiring 82 sales representatives to target over half of the 11,000 nephrologists in the U.S. [23] Clinical Efficacy and Safety - **Efficacy Measures**: Aims to stabilize eGFR, reduce proteinuria, and resolve kidney inflammation [9][12] - **Safety Profile**: Atacicept showed a low rate of serious adverse events (0.5%) and was well tolerated [12] Future Opportunities - **Expansion Potential**: Atacicept has therapeutic potential in other autoimmune diseases, with an estimated addressable market of 1.2 million patients in the U.S. [17][18] - **Pipeline Development**: Ongoing studies for additional indications and formulations, including a monthly dosing option [29][31] Conclusion - **Transformative Year Ahead**: Vera Therapeutics is positioned for significant growth in 2026 with the anticipated launch of Atacicept and ongoing clinical trials [18][34]

BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera Therapeutics”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced that the Company’s management team will present at the 44th Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 12-15, 2026. The management team will also participate in one-on-one investor m ...

The company has a fine chance of commercializing its leading investigational drug in the near future.One of the happiest moments an investor in the biotech sector can have is when one of his or her companies reports a regulatory submission for a promising product. Sure enough, investors snapped up shares of Vera Therapeutics (VERA +4.64%) on Wednesday, sending them to a nearly 5% gain, on the company's news that it made such a filing. FDA decision coming soonThat morning, Vera announced that its biologics l ...

Vera Therapeutics Inc. (NASDAQ:VERA) stock rose Wednesday after the U.S. Food and Drug Administration (FDA) accepted the company’s atacicept Biologics License Application (BLA) for Priority Review.The application covers adults with immunoglobulin A nephropathy (IgAN).IgAN is an autoimmune disease of the kidney. In at least 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure.Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits ...

Core Viewpoint - Vera Therapeutics announced that the Biologics License Application (BLA) for atacicept, aimed at treating adults with immunoglobulin A nephropathy (IgAN), has been accepted for Priority Review by the FDA, with a target action date of July 7, 2026. If approved, atacicept will provide a self-administered, once-weekly subcutaneous injection for patients [1][7]. Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [11]. Product Details - Atacicept is an investigational recombinant fusion protein that targets B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are cytokines involved in the production of autoantibodies associated with IgAN and other autoimmune kidney diseases [4][11]. - The drug is designed for at-home self-administration, allowing patients to receive treatment conveniently [1][11]. Clinical Trial Results - The BLA submission for atacicept is supported by data from the ORIGIN 3 trial, which demonstrated a 46% reduction in proteinuria from baseline and a statistically significant 42% reduction compared to placebo at week 36 [2][5]. - The ORIGIN Phase 2b clinical trial met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of estimated glomerular filtration rate (eGFR) compared to placebo [5][6]. Regulatory Status - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to provide substantial improvement over existing therapies [9][7]. - The FDA's Priority Review designation highlights the urgent need for new therapies in the IgAN treatment landscape [2][7]. Future Prospects - The ongoing ORIGIN 3 trial involves 431 adults with IgAN and aims to evaluate the long-term effects of atacicept on kidney function, with results expected in 2027 [6][8]. - Vera Therapeutics is also exploring atacicept's efficacy in other autoimmune diseases, expanding its potential market [10][11].

Core Viewpoint - Vera Therapeutics' stock experienced a significant increase of nearly 13% following a bullish research note from analyst Ryan Deschner, who maintains a strong buy recommendation and a price target of $73 per share [1][2]. Group 1: Analyst Insights - Ryan Deschner of Raymond James reiterated a strong buy recommendation for Vera Therapeutics, maintaining a price target of $73 per share [2]. - Deschner's analysis focused on atacicept, a leading pipeline drug for treating IgA nephropathy, highlighting its potential competitive pricing advantage over a newly FDA-approved competitor [3]. Group 2: Competitive Landscape - Otsuka Pharmaceutical's Voyxact, a competitor recently approved by the FDA, is priced at $30,000 for a treatment every four weeks, which is approximately double the expected cost of atacicept [3]. - If Deschner's pricing assumption for atacicept is accurate, Vera Therapeutics could have a significant market advantage if the drug successfully completes clinical trials and receives regulatory approval [6]. Group 3: Market Data - Vera Therapeutics' current stock price is $37.25, with a market capitalization of $2 billion [4]. - The stock has shown a day's range between $32.92 and $39.81, with a trading volume of 4.4 million shares [5].

Summary of Vera Therapeutics FY Conference Call (December 02, 2025) Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Focus**: Development of atacicept for IgA nephropathy and other autoimmune diseases - **Key Milestone**: Preparing for US commercial launch in 2026 after a successful 2025, including phase 3 results presentation and BLA filing on November 7, 2025 [2][5][30] Core Points and Arguments Clinical Development - **Phase 3 Results**: Atacicept showed significant efficacy in IgA nephropathy, with a two-year eGFR stability, indicating a strong therapeutic effect [2][4] - **Efficacy Measurement**: Efficacy is primarily measured by estimated glomerular filtration rate (eGFR), with atacicept demonstrating a slope of GFR at -0.6, significantly better than the general population [4] - **Safety Profile**: Safety of atacicept is comparable to placebo, with no evidence of neutralizing antidrug antibodies observed in phase 2 and phase 3 trials [6][7][8] Market Positioning - **Commercial Readiness**: Vera has established a commercial leadership team and is prepared for the US launch, with a focus on pricing strategies influenced by competitor pricing [5][30][26] - **Pricing Expectations**: Current market prices for similar drugs range from $160,000 to $500,000 per patient per year, with Vera planning for various pricing scenarios based on efficacy and safety [26][27] Future Development Plans - **PIONEER Trial**: A phase 2 trial designed to study atacicept in a broader patient population with IgA nephropathy, including those not eligible for previous trials [10][12] - **Expansion into Other Indications**: Vera is exploring additional indications beyond nephrology, including membranous nephropathy and FSGS, with potential for a multi-billion dollar market [33][32] Competitive Landscape - **Differentiation**: Atacicept is positioned as a best-in-class therapy due to its efficacy and safety profile, with a focus on low-volume autoinjector delivery [4][25] - **Market Dynamics**: The first approved drug in the class may create opportunities for fast followers like Vera to establish a leadership position [29] Other Important Insights - **Provider Awareness**: Post-ASN, awareness of atacicept among providers is reportedly high, indicating strong interest and potential market uptake [9] - **Regulatory Strategy**: Vera is considering a strategic approach to regulatory submissions for new dosing regimens, aiming for a comprehensive update in 2026 [22][21] - **Long-term Vision**: Vera aims to be a dominant player in the BAFF APRIL space, with ongoing research into various autoimmune diseases [23][32] This summary encapsulates the key points discussed during the conference call, highlighting Vera Therapeutics' strategic direction, clinical advancements, and market positioning as it prepares for a significant launch in 2026.

Core Insights - Vera Therapeutics has appointed James R. Meyers to its Board of Directors, bringing over three decades of biopharmaceutical commercial leadership experience [1][2] - The company is preparing to launch atacicept, a dual BAFF/APRIL inhibitor, aimed at transforming the treatment of IgA nephropathy and other autoimmune diseases [2][3] - Meyers' expertise in commercial operations and market access is expected to support the anticipated launch and growth of atacicept [2][3] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is a fusion protein administered as a subcutaneous injection that targets BAFF and APRIL, which are involved in the production of autoantibodies [3] - The company also holds an exclusive license for VT-109, a next-generation fusion protein, and is developing MAU868, a monoclonal antibody for BK virus infection in kidney transplant recipients [3] Leadership Background - James R. Meyers previously served as Executive Vice President at Gilead Sciences, where he was instrumental in launching successful products in HIV and HCV, contributing to Gilead's revenue of over $28 billion in 2024 [2][3] - Meyers has held various leadership roles in the biopharmaceutical industry, including positions at AstraZeneca and IntraBio Ltd [2]