Monopar Therapeutics Inc. Overview
Pro stress-test →Monopar Therapeutics is a clinical-stage biotechnology company developing novel radiopharmaceuticals for oncology and a new treatment for Wilson Disease, a rare genetic disorder. The company is preparing for planned submission of a New Drug Application (NDA) to the FDA in the first half of 2026 for ALXN1840, its late-stage investigational therapy for Wilson disease.
Strategic Profile
Pro stress-test →The team consists of individuals with deep experience in rare diseases, including co-founding the successful orphan drug development companies BioMarin, Raptor Pharma, and Wilson Therapeutics. Recent leadership expansion includes appointment of Chief Commercial and Strategy Officer to build commercial infrastructure ahead of the planned FDA NDA submission.
Competitive Landscape
Pro stress-test →Monopar operates in the rare disease and radiopharmaceutical oncology space, competing against larger pharma companies and specialized biopharmaceutical firms developing Wilson disease treatments and cancer radiopharmaceuticals. The company's differentiation comes from its experienced rare disease management team and proprietary uPAR-targeting radiopharmaceutical platform.
Industry Context
Monopar Therapeutics Inc. operates in Biopharmaceutical / Clinical-Stage Therapeutics (Rare Diseases & Radiopharmaceutical Oncology).
Key facts
Founded: 2014 · Headquarters: Wilmette, Illinois, US · Market cap: $385.1M