Accelerated FDA approval for Tarpeyo sees Calliditas soar

Swedish biotech firm Calliditas Therapeutics (STO: CALTX) late yesterday announced that the US Food and Drug Administration has approved Tarpeyo (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.

Shares of Calliditas leapt more than 57% to 114.80 Swedish kronor in early trading.

This indication is approved under accelerated approval. 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.