Vera Therapeutics shares soar on positive Phase 3 trial results

Investing.com -- Shares of Vera Therapeutics , Inc. (NASDAQ:VERA) surged 80% following the announcement of positive results from its ORIGIN Phase 3 trial of atacicept, a potential treatment for immunoglobulin A nephropathy (IgAN). The company reported that atacicept met the primary endpoint in the trial, achieving a significant 46% reduction in proteinuria compared to baseline and a 42% reduction compared to placebo at week 36.

The trial’s success has been a critical driver for the stock’s movement, as the results suggest a promising future for the drug and its potential impact on IgAN treatment. The safety profile of atacicept was also favorable and comparable to placebo, which is an important consideration in the drug’s development and regulatory approval process.

Vera Therapeutics plans to engage with the FDA in the coming weeks to discuss the trial results and the regulatory pathway forward. The company’s goal is to submit a Biologics License Application (BLA) for accelerated approval in the fourth quarter of 2025. If approved, atacicept could be launched commercially in the United States in 2026.

The ORIGIN Phase 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN. Participants received atacicept 150 mg through self-administered weekly subcutaneous injections or a placebo. The trial is set to continue in a placebo-controlled blinded manner to further evaluate the change in kidney function over two years, with results expected to be completed in 2027.

The company’s CEO, Marshall Fordyce, M.D., expressed optimism about atacicept’s potential to advance the standard of care for IgAN and the company’s readiness for a potential commercial launch in 2026. He also highlighted Vera’s ambition to transform the practice of kidney medicine, aiming to help patients avoid dialysis or transplantation in the future.

The positive sentiment is shared by Richard Lafayette, M.D., a primary investigator for the ORIGIN trials, who noted the significant impact of atacicept in reducing proteinuria. Additionally, Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation, acknowledged the progress in developing new treatments for patients, which could alleviate the clinical uncertainty and quality of life issues associated with IgAN.

As the company prepares for its next steps with regulatory authorities, investors and patients alike are watching closely, with hopes that atacicept will become a new standard in IgAN therapy.

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