Vera Therapeutics, Inc. (NASDAQ:VERA) saw its stock soar by 80% following the announcement of encouraging data from its ORIGIN Phase 3 trial evaluating atacicept, a potential treatment for immunoglobulin A nephropathy (IgAN). The trial demonstrated that atacicept significantly reduced proteinuria – a key marker of kidney damage – by 46% from baseline and 42% versus placebo at week 36, meeting the study’s primary endpoint.
This milestone marks a pivotal moment for Vera Therapeutics, signaling a promising future for atacicept in addressing IgAN, a chronic kidney disease. The drug also exhibited a safety profile comparable to placebo, a crucial factor for regulatory approval.
Vera Therapeutics plans to initiate discussions with the FDA soon to outline the next steps for regulatory review. The company aims to submit a Biologics License Application (BLA) seeking accelerated approval by Q4 2025, with a potential U.S. commercial launch slated for 2026.
The ORIGIN trial is a large-scale, global study involving 431 adults with IgAN. Participants received weekly 150 mg subcutaneous injections of atacicept or placebo. The study continues under a blinded, placebo-controlled design to assess kidney function changes over two years, with full results expected in 2027.
CEO Dr. Marshall Fordyce expressed confidence in atacicept’s potential to reshape IgAN treatment and reduce the need for dialysis or transplantation. He emphasized the company’s commitment to advancing kidney care.
The trial’s lead investigator, Dr. Richard Lafayette, praised the significant proteinuria reduction, while Bonnie Schneider, cofounder of the IgA Nephropathy Foundation, welcomed the progress as a hopeful step toward improving patients’ quality of life.
With regulatory engagements on the horizon, patients, investors, and the medical community are optimistic about atacicept becoming a new treatment standard for IgAN.