Vera Therapeutics Receives FDA Priority Review for Atacicept BLA
Written by Emily J. Thompson, Senior Investment Analyst
Source: Benzinga
- FDA Review Progress: Vera Therapeutics' atacicept Biologics License Application (BLA) has been accepted for Priority Review by the FDA, with a target decision date of July 7, 2026, which, if approved, will provide IgAN patients with a self-administered weekly injection, significantly enhancing their quality of life.
- Clinical Data Support: The application is backed by interim analysis data from the ORIGIN 3 trial, demonstrating a 46% reduction in proteinuria at week 36, with a statistically significant 42% improvement compared to placebo, indicating its potential in treating autoimmune kidney diseases.
- Broad Market Outlook: Analysts forecast peak sales of atacicept could reach $3 billion by 2037, reflecting its potential as a favorable treatment option across multiple autoimmune disorders, which may exceed market consensus and alleviate competitive concerns.
- Positive Stock Reaction: Following the FDA's acceptance of the application, Vera Therapeutics' stock rose by 4.49% to $48.61, indicating market optimism regarding the future of its product offerings.
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Analyst Views on VERA
Wall Street analysts forecast VERA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VERA is 74.08 USD with a low forecast of 33.00 USD and a high forecast of 100.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
12 Analyst Rating
11 Buy
1 Hold
0 Sell
Strong Buy
Current: 45.110
Low
33.00
Averages
74.08
High
100.00
Current: 45.110
Low
33.00
Averages
74.08
High
100.00
About VERA
Vera Therapeutics, Inc. is a late-stage biotechnology company. The Company 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 Appoints New Chief Commercial Officer
- Executive Appointment: Vera Therapeutics has appointed Matt Skelton as Chief Commercial Officer to prepare for the commercial launch of atacicept for IgA nephropathy, leveraging his extensive experience in building commercial organizations to facilitate the company's transition to a commercial-stage entity.
- Drug Potential: Atacicept, a dual BAFF/APRIL inhibitor, shows promising clinical data and the advantage of self-administration at home, with Skelton emphasizing a focus on enhancing treatment outcomes for IgAN patients, potentially transforming their quality of life.
- Clinical Trial Progress: Atacicept met its primary and key secondary endpoints in the ORIGIN Phase 2b trial, demonstrating significant reductions in proteinuria and stabilization of kidney function, which is expected to lay the groundwork for future FDA approval.
- Regulatory Advancements: The Biologics License Application (BLA) for atacicept has received Priority Review designation, with a PDUFA target action date of July 7, 2026, which, if approved, will provide new treatment options for IgAN patients and further solidify the company's market position.
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Vera Therapeutics Grants 344,750 Stock Options and RSUs to New Employees
- Inducement Plan Implementation: On January 5, 2026, Vera Therapeutics granted 344,750 stock options and RSUs to 18 new employees, aimed at attracting and retaining talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Stock Option Details: Each stock option has an exercise price of $47.07, based on the closing price on the grant date, and will vest over four years, enhancing employee long-term incentives and loyalty to the company.
- Restricted Stock Units Arrangement: The RSUs will vest over four years, with the first vesting occurring on February 20, 2026, ensuring continued contributions from new employees during their service with the company.
- Strategic Company Direction: The stock options and RSUs granted reflect Vera Therapeutics' commitment to talent acquisition, aiming to drive innovation in the treatment of immunological diseases by attracting high-quality employees.
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