Calliditas Therapeutics

IgA nephropathy (IgAN) is a common autoimmune kidney disease characterized by IgA deposits, leading to progressive damage and chronic kidney disease (CKD). 40-53% of patients progress to end-stage renal disease (ESRD) within two decades, necessitating interventions like dialysis or transplantation. The treatment landscape for IgAN is evolving with ongoing phase 3 trials for 11 agents, including budesonide and sparsentan, which have received FDA approval. Early detection and intervention are crucial to delay progression, reduce healthcare costs, and improve patient outcomes.

Travere Therapeutics' stock surged after FDA full approval for kidney disease treatment Filspari, expanding market potential to over 70,000 IgA patients in the U.S. and raising peak sales estimates to $661 million. The approval aligns with Calliditas Therapeutics' similar FDA approval for Tarpeyo in December 2023.

Travere Therapeutics receives FDA full approval for Filspari (sparsentan) to slow kidney function decline in IgAN patients. Filspari is an oral, once-daily, non-immunosuppressive medication targeting two key pathways in IgAN progression. The approval is based on the Phase 2 PROTECT Study results showing significant kidney function preservation compared to irbesartan.

FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.

NOX inhibitors, including Calliditas Therapeutics' setanaxib, show potential in treating fibrotic diseases and cancers by reducing ROS levels, thereby allowing CD8+ T-cells to penetrate tumors and enhance immune response. Setanaxib has shown promising results in Phase II trials for squamous cell carcinoma of the head and neck, with plans for further trials in primary biliary cholangitis and Alport Syndrome.

FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.