Vera shares skyrocket as kidney disease drug succeeds in late-stage trial
The drug developer's shares surged to $34.24 in premarket trading, giving it a market value of $2.18 billion, if gains hold.
The drug, atacicept, reduced protein levels in the urine by 46% in patients with IgA nephropathy, which was statistically significant compared to a placebo, meeting the main goal of the study, the company said.
In IgA nephropathy, there is a buildup of proteins that causes inflammation in kidneys, which is indicated by their presence in the patient's urine.
The late-stage study data beat investor's expectations, which were based on the 35% reduction seen in the mid-stage study of the drug, said Evercore ISI analyst Liisa Bayko in a note.
Vera plans to submit a marketing application to the FDA in fourth-quarter and expects for potential commercial launch in 2026 in the United States. The study will continue to test the change in kidney function over two years and is expected to complete in 2027.
Rival Japan-based firm Otsuka Holdings (4578.T), opens new tab has already filed for a marketing application to the U.S. Food and Drug Administration for its kidney disease drug, sibeprenlimab. That drug is expected to reach the market six to nine months ahead of Vera's atacicept, Bayko said.
In a separate mid-stage trial, Otsuka's drug had helped reduce levels of excess proteins by 43%, according to Evercore.
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