Vera Therapeutics Advances Atacicept Approval Process with FDA Support
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 28 2024
0mins
Source: Business Insider
Vera Therapeutics' stock rose by 5.44% as it crossed above the 5-day SMA, reflecting positive investor sentiment following recent FDA developments.
The company has aligned with the FDA to expedite the ORIGIN 3 eGFR analysis for Atacicept, now expected in Q3 2026, and plans to submit a supplemental Biologics License Application in Q4 2026. This could lead to full approval in 2027, marking a significant milestone for the first therapy targeting both BAFF and APRIL for IgAN patients. The ORIGIN Phase 2b trial results showed that Atacicept significantly reduced proteinuria and stabilized eGFR, laying a strong foundation for the upcoming Phase 3 trial.
These developments position Vera Therapeutics favorably in the market, especially with the FDA Breakthrough Therapy Designation for Atacicept, indicating its potential to outperform existing therapies for IgAN. Investors are optimistic about the company's strategic plans and market potential.
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Analyst Views on VERA
Wall Street analysts forecast VERA stock price to rise
12 Analyst Rating
11 Buy
1 Hold
0 Sell
Strong Buy
Current: 35.010
Low
33.00
Averages
74.08
High
100.00
Current: 35.010
Low
33.00
Averages
74.08
High
100.00
About VERA
Vera Therapeutics, Inc. is a clinical stage biotechnology company. It is focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Its lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger's disease, and lupus nephritis. In addition, it is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. It is also engaged in developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. It retains all global developmental and commercial rights to atacicept and MAU868.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Vera Therapeutics Advances Atacicept for IgA Nephropathy with FDA Agreement
- Key Data Timeline: The key kidney function data from the ORIGIN 3 study is now expected in Q3 2026, and if positive, Vera plans to submit a supplemental Biologics License Application in Q4 2026, potentially accelerating market access for atacicept.
- FDA Agreement: Vera Therapeutics has reached an agreement with the FDA on an earlier analysis plan for the ORIGIN 3 late-stage trial, which could expedite the full approval process for atacicept in adults with IgA nephropathy, although this news did not prevent a 5.8% drop in stock price.
- Clinical Trial Success: The ORIGIN Phase 2b trial met its primary and key secondary endpoints, demonstrating reduced proteinuria and stable kidney function over 36 weeks, while the Phase 3 trial also showed promising interim results, indicating atacicept's potential in treating IgA nephropathy.
- Market Sentiment Shift: Despite VERA's stock being down nearly 40% year-to-date, sentiment on Stocktwits has shifted from “bearish” to “neutral,” reflecting cautious optimism among investors regarding the company's future prospects.
See More
Vera Therapeutics Accelerates Atacicept Approval Process
- FDA Support for Atacicept: Vera Therapeutics has aligned with the FDA to conduct the ORIGIN 3 eGFR analysis earlier, now expected in Q3 2026, and plans to submit a supplemental Biologics License Application in Q4 2026, potentially leading to full approval in 2027, which would provide the first therapy targeting both BAFF and APRIL for IgAN patients.
- Significant Clinical Trial Results: The ORIGIN Phase 2b trial demonstrated that atacicept significantly reduced proteinuria and stabilized eGFR in IgAN patients, with a safety profile comparable to placebo, laying a solid foundation for the subsequent Phase 3 trial, which is expected to further validate its clinical efficacy.
- Substantial Market Potential: Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly outperform existing therapies for IgAN, positioning Vera Therapeutics to capture a leading market share in a high-demand therapeutic area.
- Expansion Research Plans: Vera Therapeutics is conducting a dose range-finding study for atacicept and plans to evaluate its efficacy in other autoimmune diseases beyond IgAN, showcasing the company's strategic foresight and potential for market expansion.
See More
Rhenman Exits Entire Stake in Vera Therapeutics
- Complete Exit: Rhenman & Partners Asset Management AB sold its entire 420,000-share stake in Vera Therapeutics during Q1 2026 for approximately $18.1 million, indicating a significant reduction in confidence in the company.
- Asset Value Decline: Prior to the sale, the value of Vera Therapeutics' position decreased by $21.27 million at quarter-end, reflecting the dual impact of market price fluctuations and share sales, highlighting the pressures faced by the company.
- Strong Stock Performance: As of May 13, 2026, Vera Therapeutics shares traded at $39.15, marking an 81.4% increase over the past year, significantly outperforming the S&P 500 by 55 percentage points, showcasing its robust performance in the biotech sector.
- Investment Risk Advisory: Despite a 378% increase in stock price over the past three years, Vera Therapeutics remains a biotech stock subject to volatility, particularly due to clinical data releases and drug approval processes, necessitating careful risk assessment by investors.
See More
Rhenman & Partners Exits Entire Stake in Vera Therapeutics
- Complete Exit: Rhenman & Partners Asset Management AB sold its entire 420,000-share stake in Vera Therapeutics during Q1 2026 for an estimated $18.10 million, indicating a significant reduction in confidence in the stock.
- Impact on AUM: The sale resulted in a decline of approximately $21.27 million in the position's value quarter over quarter, reflecting the dual impact of market price movements and share sales, leading to a zero percent allocation in the fund's 13F assets.
- Stock Performance Review: While Vera Therapeutics' stock has surged 81.4% over the past year and 378% over the last three years, it still carries volatility risks associated with clinical data releases and drug approval processes, necessitating careful investor consideration.
- Market Competition Analysis: Despite Vera Therapeutics' potential in the immunology therapeutics market, it was not included in The Motley Fool's current list of the top ten stocks to buy, suggesting a cautious market outlook on its future performance.
See More
Vera Therapeutics Reports Q1 Financial Results
- Financial Performance: Vera Therapeutics reported a Q1 GAAP EPS of -$1.69, indicating significant challenges in profitability that could impact investor confidence and lead to stock price volatility.
- Cash Flow Situation: For the quarter ending March 31, 2026, net cash used in operating activities was $106.5 million, a substantial increase from $54.4 million in the same quarter of 2025, suggesting pressure on the company's financial management that may affect future investment capabilities.
- Market Reaction: Analysts downgraded the rating to Hold based on the reassessment of Atacicept's potential in treating IgAN, reflecting a cautious market sentiment regarding the company's product prospects, which may lead to decreased investor confidence in future growth.
- Industry Conference: Vera Therapeutics presented at the TD Cowen 46th Annual Health Care Conference, actively seeking to communicate with investors despite financial challenges, showcasing its ongoing efforts in the healthcare sector.
See More
Vera Therapeutics to Present at Bank of America Health Care Conference
- Conference Participation: Vera Therapeutics' management team will present at the Bank of America Securities Health Care Conference on May 13, 2026, at 4:20 PM in Las Vegas, aiming to enhance the company's visibility and credibility among investors through one-on-one meetings.
- Lead Product Candidate: The company's lead product candidate, atacicept, is a self-administered weekly subcutaneous injection designed to treat serious immunological diseases by blocking BAFF and APRIL, which is expected to change the standard of care for conditions like IgA nephropathy and lupus nephritis.
- Research and Development Potential: Vera is also evaluating the clinical significance of atacicept in additional autoimmune diseases, showcasing its potential applications across a wide range of B-cell-mediated diseases, thereby enhancing its competitive position in the market.
- Exclusive Licensing Agreement: The company holds an exclusive license agreement with Stanford University for the development of the next-generation fusion protein VT-109, which is anticipated to offer broad therapeutic potential for B-cell-related diseases, further solidifying its research foundation.
See More
Vera Therapeutics Advances Atacicept for IgA Nephropathy with FDA Agreement
- Key Data Timeline: The key kidney function data from the ORIGIN 3 study is now expected in Q3 2026, and if positive, Vera plans to submit a supplemental Biologics License Application in Q4 2026, potentially accelerating market access for atacicept.
- FDA Agreement: Vera Therapeutics has reached an agreement with the FDA on an earlier analysis plan for the ORIGIN 3 late-stage trial, which could expedite the full approval process for atacicept in adults with IgA nephropathy, although this news did not prevent a 5.8% drop in stock price.
- Clinical Trial Success: The ORIGIN Phase 2b trial met its primary and key secondary endpoints, demonstrating reduced proteinuria and stable kidney function over 36 weeks, while the Phase 3 trial also showed promising interim results, indicating atacicept's potential in treating IgA nephropathy.
- Market Sentiment Shift: Despite VERA's stock being down nearly 40% year-to-date, sentiment on Stocktwits has shifted from “bearish” to “neutral,” reflecting cautious optimism among investors regarding the company's future prospects.
See More
Vera Therapeutics Accelerates Atacicept Approval Process
- FDA Support for Atacicept: Vera Therapeutics has aligned with the FDA to conduct the ORIGIN 3 eGFR analysis earlier, now expected in Q3 2026, and plans to submit a supplemental Biologics License Application in Q4 2026, potentially leading to full approval in 2027, which would provide the first therapy targeting both BAFF and APRIL for IgAN patients.
- Significant Clinical Trial Results: The ORIGIN Phase 2b trial demonstrated that atacicept significantly reduced proteinuria and stabilized eGFR in IgAN patients, with a safety profile comparable to placebo, laying a solid foundation for the subsequent Phase 3 trial, which is expected to further validate its clinical efficacy.
- Substantial Market Potential: Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly outperform existing therapies for IgAN, positioning Vera Therapeutics to capture a leading market share in a high-demand therapeutic area.
- Expansion Research Plans: Vera Therapeutics is conducting a dose range-finding study for atacicept and plans to evaluate its efficacy in other autoimmune diseases beyond IgAN, showcasing the company's strategic foresight and potential for market expansion.
See More
Rhenman Exits Entire Stake in Vera Therapeutics
- Complete Exit: Rhenman & Partners Asset Management AB sold its entire 420,000-share stake in Vera Therapeutics during Q1 2026 for approximately $18.1 million, indicating a significant reduction in confidence in the company.
- Asset Value Decline: Prior to the sale, the value of Vera Therapeutics' position decreased by $21.27 million at quarter-end, reflecting the dual impact of market price fluctuations and share sales, highlighting the pressures faced by the company.
- Strong Stock Performance: As of May 13, 2026, Vera Therapeutics shares traded at $39.15, marking an 81.4% increase over the past year, significantly outperforming the S&P 500 by 55 percentage points, showcasing its robust performance in the biotech sector.
- Investment Risk Advisory: Despite a 378% increase in stock price over the past three years, Vera Therapeutics remains a biotech stock subject to volatility, particularly due to clinical data releases and drug approval processes, necessitating careful risk assessment by investors.
See More
Rhenman & Partners Exits Entire Stake in Vera Therapeutics
- Complete Exit: Rhenman & Partners Asset Management AB sold its entire 420,000-share stake in Vera Therapeutics during Q1 2026 for an estimated $18.10 million, indicating a significant reduction in confidence in the stock.
- Impact on AUM: The sale resulted in a decline of approximately $21.27 million in the position's value quarter over quarter, reflecting the dual impact of market price movements and share sales, leading to a zero percent allocation in the fund's 13F assets.
- Stock Performance Review: While Vera Therapeutics' stock has surged 81.4% over the past year and 378% over the last three years, it still carries volatility risks associated with clinical data releases and drug approval processes, necessitating careful investor consideration.
- Market Competition Analysis: Despite Vera Therapeutics' potential in the immunology therapeutics market, it was not included in The Motley Fool's current list of the top ten stocks to buy, suggesting a cautious market outlook on its future performance.
See More
Vera Therapeutics Reports Q1 Financial Results
- Financial Performance: Vera Therapeutics reported a Q1 GAAP EPS of -$1.69, indicating significant challenges in profitability that could impact investor confidence and lead to stock price volatility.
- Cash Flow Situation: For the quarter ending March 31, 2026, net cash used in operating activities was $106.5 million, a substantial increase from $54.4 million in the same quarter of 2025, suggesting pressure on the company's financial management that may affect future investment capabilities.
- Market Reaction: Analysts downgraded the rating to Hold based on the reassessment of Atacicept's potential in treating IgAN, reflecting a cautious market sentiment regarding the company's product prospects, which may lead to decreased investor confidence in future growth.
- Industry Conference: Vera Therapeutics presented at the TD Cowen 46th Annual Health Care Conference, actively seeking to communicate with investors despite financial challenges, showcasing its ongoing efforts in the healthcare sector.
See More
Vera Therapeutics to Present at Bank of America Health Care Conference
- Conference Participation: Vera Therapeutics' management team will present at the Bank of America Securities Health Care Conference on May 13, 2026, at 4:20 PM in Las Vegas, aiming to enhance the company's visibility and credibility among investors through one-on-one meetings.
- Lead Product Candidate: The company's lead product candidate, atacicept, is a self-administered weekly subcutaneous injection designed to treat serious immunological diseases by blocking BAFF and APRIL, which is expected to change the standard of care for conditions like IgA nephropathy and lupus nephritis.
- Research and Development Potential: Vera is also evaluating the clinical significance of atacicept in additional autoimmune diseases, showcasing its potential applications across a wide range of B-cell-mediated diseases, thereby enhancing its competitive position in the market.
- Exclusive Licensing Agreement: The company holds an exclusive license agreement with Stanford University for the development of the next-generation fusion protein VT-109, which is anticipated to offer broad therapeutic potential for B-cell-related diseases, further solidifying its research foundation.
See More
