Vera Therapeutics reported positive Phase 3 results for atacicept in IgA nephropathy, with the experimental drug achieving a 46% reduction in proteinuria that exceeded investor expectations and drove shares up over 65% in pre-market trading. The company plans to submit a marketing application to the FDA in the fourth quarter of 2025, targeting a potential commercial launch in 2026.
Phase 3 Trial Results Exceed Expectations
The pivotal ORIGIN 3 trial demonstrated that atacicept achieved a statistically significant 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a clinically meaningful 42% reduction compared to placebo at week 36. These results surpassed the 35% reduction observed in the drug's mid-stage study, according to Evercore ISI analyst Liisa Bayko.
The strong efficacy data represents an unusual achievement in drug development, with atacicept appearing more effective in Phase 3 than it was in Phase 2 trials. Vera's shares surged to $34.24 in premarket trading, giving the company a market value of $2.18 billion if gains hold.
Addressing Serious Kidney Disease
IgA nephropathy, also known as Berger's disease, is a serious and progressive autoimmune disease of the kidney characterized by a buildup of proteins that causes inflammation. The condition affects patients through symptoms including proteinuria (protein in the urine causing foamy or bubbly urine) and hematuria (blood in the urine).
The disease represents a significant medical burden, with up to 50% of patients potentially progressing to end-stage kidney disease (ESKD) or kidney failure, which has considerable morbidity and impact on patients' lives. The presence of proteins in urine serves as an indicator of kidney inflammation in IgA nephropathy patients.
Competitive Landscape and Market Timeline
Vera faces competition from Japan-based Otsuka Holdings, which has already filed a marketing application with the FDA for its kidney disease drug sibeprenlimab. Otsuka's drug is expected to reach the market six to nine months ahead of atacicept, according to Bayko's analysis.
In a separate mid-stage trial, Otsuka's sibeprenlimab demonstrated a 43% reduction in excess protein levels, according to Evercore data. This positions both drugs as potentially effective treatments for the condition, though atacicept's 46% reduction suggests a slight efficacy advantage.
Development Timeline and Future Plans
Vera Therapeutics intends to bring the ORIGIN 3 results before the FDA by the end of 2025, with the company anticipating approval and commercial launch in 2026. The ongoing study will continue to evaluate changes in kidney function over two years and is expected to complete in 2027, providing additional long-term efficacy and safety data.
The company's stock performance reflects investor confidence in the drug's commercial potential, with shares trading around $20.50 in early April before reaching an intraday high of $32, representing significant gains following the positive trial results.
