Vera Therapeutics Stock Jumps After Positive Phase 3 Data for Kidney Drug TRUTAKNA

Shares of Vera Therapeutics (NASDAQ:VERA) surged 13% on Tuesday after the company announced positive final efficacy results from its Phase 3 ORIGIN trial. The study evaluated TRUTAKNA (atacicept-vymj) for the treatment of IgA nephropathy (IgAN), a chronic kidney disease.

Key Trial Results

The company reported that the trial, which included 428 patients, met all of its prespecified endpoints. The data showed that TRUTAKNA effectively stabilized kidney function and prevented disease progression over a two-year period in adults with IgAN at high risk of progression.

Key findings from the final analysis include:

• Kidney Function Preservation: At 52 weeks, patients receiving TRUTAKNA experienced a mean change in estimated glomerular filtration rate (eGFR) of -0.1 mL/min/1.73m² from baseline, compared to a decline of -5.7 mL/min/1.73m² for those on placebo.
• Reduced Progression: The drug demonstrated a 76% risk reduction in composite kidney disease progression events over 104 weeks, with 11 events in the treatment group versus 38 in the placebo group.
• Favorable Safety: The safety profile of TRUTAKNA was reported as favorable and generally comparable to placebo, with similar rates of overall adverse events and infections.

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Path to Full Approval

Following these positive results, Vera Therapeutics plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2026. The submission will seek full approval for TRUTAKNA.

The drug, which is the first FDA-approved inhibitor of both BAFF and APRIL, currently holds an accelerated approval. The company noted a strong commercial launch, with over 350 patient start forms generated in the first ten weeks post-launch, indicating early market adoption.