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FDA Grants Calliditas Accelerated Approval Of Tarpeyo To Reduce Proteinuria In IgA Nephropathy

The U.S. Food and Drug Administration has approved Tarpeyo or budesonide delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy or IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) =1.5g/g. The indication is approved under accelerated approval, Calliditas Therapeutics AB (CALT) said in a statement.

CALT closed Wednesday regular trading at $18.64 up $1.99 or 11.95%. In the after-hours trade, the stock further gained $10.02 or 53.73%.

It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

The company expects that Tarpeyo will be available in the U.S. early in the first quarter of 2022.

IgAN is a rare, progressive autoimmune disease, which has a high unmet need with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

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