By Stephen Nakrosis
Shares of Calliditas Therapeutics were topping previous 52-week highs in Wednesday’s late-trading session after the company said the U.S. Food and Drug Administration approved Tarpeyo to treat certain patients with primary immunoglobulin A nephropathy.
At 4:54 p.m. ET, the company’s stock had risen 33%, to $29.96 a share. The stock hit a 52-week high of $25.64 on May 8.
The FDA approved Tarpeyo, or budesonide, delayed release capsules “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy at risk for disease progression,” Calliditas said.
Tarpeyo, the first fully FDA-approved treatment for IgAN based on a measure of kidney function, was first approved in December 2021 under accelerated approval, the company said.
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