Investors are closely watching Vera Therapeutics Inc. (NASDAQ:VERA) as the company awaits the U.S. Food and Drug Administration (FDA) decision for its rare kidney disease drug.
• Vera Therapeutics stock is building positive momentum. Why is VERA stock advancing?
Vera Therapeutics Awaits Key FDA Decision
Over the past month, the stock has gained around 30%.
With the action date on July 7, the company seeks accelerated approval of atacicept in patients with IgA Nephropathy (IgAN), an autoimmune kidney disease that occurs when immunoglobulin A (IgA) antibodies build up in the kidneys.
The buildup causes inflammation that damages the glomeruli (tiny filters in the kidneys), making it harder to filter waste from the blood.
If approved, atacicept could offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.
ORIGIN 3 Trial Data Supports
The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial.
The trial met the primary endpoint of reduction in proteinuria at week 36.
Atacicept-treated patients achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo at week 36.
In June, Vera Therapeutics aligned with the FDA on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN.
The eGFR results are now expected in the third quarter of 2026, pulled forward from 2027. Pending these results, Vera Therapeutics plans to submit an sBLA for full approval in the fourth quarter of 2026.
In April 2025, the FDA granted accelerated approval to Novartis AG’s (NYSE:NVS) Vanrafia (atrasentan) for the reduction of proteinuria in adults with IgAN in April 2025.
Novartis Remains Key Competitor
In February, Novartis shared final results from the Phase 3 ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy (IgAN) who were treated with Vanrafia.
After the trial data, Novartis plans to submit for traditional approval in 2026.
VERA Stock Price Activity: Vera Therapeutics shares were up 1% at $41.60 at the time of publication on Monday, according to Benzinga Pro data.
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