Vera Therapeutics, Inc.

Vera Therapeutics announced the accelerated FDA approval and commercial launch of TRUTAKNA (atacicept-vymj) for adult patients with primary IgA nephropathy (IgAN) at risk for disease progression. This marks a significant milestone as TRUTAKNA is the first and only therapy to inhibit both BAFF and APRIL for IgAN. The company also reported a net loss of $109.5 million for the second quarter ended June 30, 2026, and provided updates on its clinical programs and upcoming milestones, including an earlier ORIGIN 3 final efficacy analysis and anticipated sBLA submission.

Vera Therapeutics granted inducement awards to its new Chief Regulatory Officer, Nancy Bowman, and two other new employees. These awards, approved by the Compensation Committee, include non-qualified stock options and restricted stock units (RSUs) under the 2024 Inducement Plan. The awards are designed to attract and retain talent, with specific vesting schedules over four years.

Vera Therapeutics, Inc. announced a change in its Chief Regulatory Officer role. William Turner will transition from his current position to Special Advisor for Regulatory Affairs, effective August 3, 2026. Nancy Bowman, M.D., Ph.D., will take over as the new Chief Regulatory Officer on the same date.

Vera Therapeutics announced a planned transition for its Chief Regulatory Officer position. William Turner, who successfully oversaw the accelerated approval of TRUTAKNA™ for IgA nephropathy, will retire and move into a Strategic Advisor role in the third quarter. Nancy Boman, M.D., Ph.D., with over 25 years of regulatory affairs experience from companies like Kyverna Therapeutics and Novartis Gene Therapies, will take over as the new Chief Regulatory Officer. The company anticipates Dr. Boman's expertise will be invaluable for pursuing new indications for TRUTAKNA and developing other pipeline molecules.

Vera Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted accelerated approval for TRUTAKNA™ (atacicept-vymj). This approval is specifically for reducing proteinuria in adult patients diagnosed with primary immunoglobulin A nephropathy who are at risk for disease progression.

Vera Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted TRUTAKNA (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. TRUTAKNA is the first and only therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), addressing immunological drivers of IgAN. In the ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant 42% reduction compared to placebo at 36 weeks. The approval is based on reduction of proteinuria, with continued approval contingent upon verification of clinical benefit in the ongoing ORIGIN 3 trial.

Vera Therapeutics, Inc. announced alignment with the U.S. Food and Drug Administration (FDA) on a revised, earlier ORIGIN 3 eGFR analysis plan for atacicept in adults with IgA Nephropathy (IgAN). The eGFR results are now expected in Q3 2026, pulled forward from 2027. Pending positive results, the company plans to submit a supplemental Biologics License Application (sBLA) for full approval in Q4 2026, with potential full approval in 2027. The Prescription Drug User Fee Act (PDUFA) date for accelerated approval of atacicept is July 7, 2026.

Vera Therapeutics, Inc. announced that its Compensation Committee granted inducement awards to ten new employees on May 4, 2026. These awards include non-qualified stock options to purchase 40,250 shares and restricted stock units (RSUs) underlying 20,125 shares of Class A common stock. The awards were approved as a material inducement for employment under the company's 2024 Inducement Plan. The stock options have an exercise price of $35.51 per share and both stock options and RSUs will vest over four years, subject to continued employment.

Vera Therapeutics reported a significant increase in net loss for the first quarter of 2026, reaching $121.0 million, compared to $51.7 million in the same period of 2025. This was primarily driven by a substantial rise in research and development and general and administrative expenses. While cash and cash equivalents decreased, marketable securities increased, bringing total liquidity to $596.8 million, which management believes is sufficient for at least the next 12 months. The company continues to incur net operating losses and expects to raise additional capital to fund its long-term objectives.

Vera Therapeutics announced its Q1 2026 financial results and significant business updates. The U.S. FDA granted priority review to its Biologics License Application (BLA) for atacicept in IgA Nephropathy (IgAN), setting a PDUFA date of July 7, 2026. The company is on track for a U.S. commercial launch of atacicept in mid-2026, pending regulatory approval, and expects its strong balance sheet to fund operations beyond the launch. The company reported an increased net loss for the quarter.