Calliditas Therapeutics (NASDAQ: CALT) has submitted a marketing application to the FDA seeking approval for Nefecon, an oral formulation targeting down-regulation of IgA1 for primary IgA Nephropathy (IgAN).

• IgAN, also known as Berger's disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, resulting in hampering the kidneys' ability to filter waste from the blood.
• The company has applied for accelerated approval, which allows drugs targeting serious conditions to be approved based on a surrogate endpoint.
• The surrogate endpoint in the Phase 3 trial, NefIgArd, was reducing proteinuria versus placebo and demonstrated a statistically significant reduction in the urine protein.
• A confirmatory study designed to provide data on a long-term renal benefit is fully recruited and is expected to read out in early 2023.
• The company says if approved, Nefecon would become the first therapy specifically designed and approved for the treatment of IgAN, with the potential to be disease-modifying.
• Price Action: CALT shares gained 3.6% at $31.03 in premarket trading on the last check Monday.