Calliditas Therapeutics' Kidney Disease Drug Gets FDA Approval; Stock Surges

(RTTNews) - Calliditas Therapeutics AB (CALT) said that the U.S. Food and Drug Administration has approved TARPEYO or budesonide delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy or IgAN at risk for disease progression.

CALT closed Wednesday's regular trading at $22.48 up $1.44 or 6.84%. In the after-hours trading, the stock further gained $5.95 or 26.47%.

TARPEYO was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria.

TARPEYO is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function, Calliditas said.

The approval is based on data from the company's Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter, study that assessed the efficacy and safety of TARPEYO dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN.

According to the company, TARPEYO is available exclusively through Calliditas specialty pharmacy, Biologics by McKesson.

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