CALT - Calliditas surges on FDA approval for kidney disease therapy

Calliditas Therapeutics (NASDAQ:CALT) ADRs have climbed in the post-market after the company announced the FDA approval of TARPEYO (budesonide) to address proteinuria in adults with primary immunoglobulin A nephropathy ((IgAN)). FDA clearance for TARPEYO delayed-release capsules transforms the Swedish pharma company into a commercial-stage firm as it plans to launch the therapy in the U.S. in Q1 2022. The regulatory approval for the drug was backed by positive data from Part A of the ongoing NeflgArd pivotal Phase 3 study. Licensed under the regulator’s accelerated pathway for approval, TARPEYO is still not yet proven to slow the decline in kidney function of patients with IgAN. The continuation of its regulatory clearance is subject to verification of the drug’s clinical benefit in a confirmatory clinical trial, the company noted.

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Calliditas surges on FDA approval for kidney disease therapy