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Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy

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Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for At...

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Vera Therapeutics announced that the FDA has accepted the Biologics License Application (BLA) for atacicept to treat IgAN, assigning it a target action date of July 7, 2026. The drug, which received Breakthrough Therapy Designation, demonstrated significant efficacy in reducing proteinuria during clinical trials, indicating promising potential for transforming IgAN treatment.

Trading Thesis

Positive FDA BLA acceptance could lead to significant stock price appreciation for VERA.

Market-Moving

  • FDA's Priority Review designation may signal urgency for atacicept's approval.
  • Atacicept's unique dual-target approach could reshape IgAN treatment standards.
  • Positive trial results boost confidence in VERA's commercial viability.
  • Increased investor interest expected as approval date approaches.
  • Potential market for at-home self-administration offers competitive advantage.

Key Facts

  • Atacicept received FDA Breakthrough Therapy Designation for IgAN.
  • The BLA was submitted using the Accelerated Approval Program.
  • The target action date for FDA review is July 7, 2026.
  • Atacicept led to a statistically significant 42% UPCR reduction compared to placebo.
  • The ORIGIN 3 trial involved 431 participants with IgAN.

Companies Mentioned

  • Vera Therapeutics, Inc. (VERA): Vera's approval could greatly enhance its market presence.
  • New England Journal of Medicine (N/A): Published interim trial results boost scientific credibility.

Corporate Developments

As a biotechnology company in late clinical stages, Vera Therapeutics is positioned in a competitive sector focusing on innovative therapies for autoimmune diseases. The potential approval of atacicept could significantly impact standard treatment protocols within immunology, particularly for kidney diseases like IgAN.

FAQ

Why Bullish?

Historically, FDA approvals or significant designations like Breakthrough Therapy have led to substantial stock price increases, as seen with companies like Amgen and Gilead Sciences upon analogous announcements.

How important is it?

With atacicept as a potential game-changer in IgAN treatment, its regulatory outcomes are crucial for investors and market participants, indicating high relevance to VERA's future valuation.

Why Long Term?

The PDUFA timeline indicates a longer-term impact. Successful FDA approval could lead to sustained revenue generation and growth, similar to successful drug launches in the biotech industry.

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Vera Therapeutics Receives FDA Priority Review for Atacicept in IgA Nephropathy

BRISBANE, Calif., January 7, 2026 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on innovative therapies for serious immunological diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for atacicept, aimed at treating adults with immunoglobulin A nephropathy (IgAN), for Priority Review status. This review, facilitated by the FDA’s Accelerated Approval Program, has a target Prescription Drug User Fee Act (PDUFA) action date of July 7, 2026.

Atacicept: A Potential Game-Changer for IgAN

If approved, atacicept will be the first B cell modulator targeting both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL) intended for at-home self-administration as a once-weekly subcutaneous injection. The unique dual targeting approach of atacicept is designed to advance the standard of care for patients suffering from IgAN, a condition that can lead to significant morbidity and kidney failure in more than 50% of affected individuals.

Clinical Data Supporting Atacicept’s Efficacy

The submission of the BLA is backed by data from the ORIGIN 3 trial, which showed compelling results with atacicept. Key findings include:

  • A **46% reduction** in proteinuria from baseline as measured by the 24-hour urine protein-to-creatinine ratio (UPCR).
  • A statistically significant **42% reduction** in UPCR compared to placebo (p < 0.0001).

The favorable safety profile of atacicept throughout the ORIGIN program is comparable to the placebo, reinforcing its potential as a safe treatment option for IgAN patients. Results from the interim analysis were widely presented, including at a late-breaking session during the American Society of Nephrology Kidney Week meeting and published in the New England Journal of Medicine.

The Implications of FDA’s Priority Review Designation

Vera Therapeutics’ CEO, Dr. Marshall Fordyce, emphasized the significance of the FDA's Priority Review designation, stating, “This reinforces the need for new therapies that can reshape the IgAN treatment landscape. We remain committed to ensuring that the review of the BLA is thorough and focused on delivering this potential treatment to patients as urgently as possible.”

Understanding IgA Nephropathy and Atacicept's Mechanism

IgAN is a serious autoimmune disease affecting the kidneys, characterized by the accumulation of immunoglobulin A (IgA) deposits. As a progressive condition, it often requires disease-modifying treatments targeting the underlying mechanisms of the disease. Atacicept works by inhibiting BAFF and APRIL cytokines, thereby reducing the production of autoantibodies responsible for IgAN and other autoimmune kidney diseases.

Ongoing and Future Studies

The ORIGIN Phase 2b trial demonstrated significant efficacy in proteinuria reduction and renal function stabilization compared to placebo. The ongoing Phase 3 ORIGIN 3 trial includes 431 adult participants and remains blinded to ensure robust evaluation of kidney function changes over two years, with results anticipated in 2027.

Additionally, the ORIGIN Extend study offers participants continued access to atacicept, further collecting valuable long-term safety and efficacy data. Atacicept is also being studied for various populations, including those with anti-PLA2R positive primary membranous nephropathy.

About Vera Therapeutics

Vera Therapeutics is dedicated to developing treatments for serious immunological diseases, focusing on innovation that targets the root causes of these conditions. In addition to atacicept, Vera is exploring other therapeutic avenues, including VT-109 and MAU868, aimed at addressing B-cell mediated diseases and BK virus infections in kidney transplant recipients, respectively.

Forward-Looking Statements

The information contained in this release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, regarding future events or results, including the approval of atacicept by the FDA. Such statements are subject to risks and uncertainties that could cause actual results to differ materially.

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