On August 12, 2026, Monopar Therapeutics Inc. reported financial results for the second quarter ended June 30, 2026, and announced it initiated a rolling New Drug Application (NDA) submission to the FDA on July 22, 2026, for ALXN1840, its first-in-class treatment for Wilson disease. The company reported a net loss of $5.3 million ($0.62 per share), compared to a $2.5 million loss in the prior year period, with cash and investments totaling $134.3 million sufficient to fund operations through at least December 31, 2027. R&D expenses increased to approximately $4.8 million due to higher contractor and personnel costs, while General and Administrative expenses rose to roughly $1.9 million. The filing also highlighted the appointment of Susan Rodriguez as Chief Commercial and Strategy Officer and board member Nicole Sweeny to support commercial launch preparations for ALXN1840. Monopar Therapeutics is a clinical-stage biopharmaceutical company developing innovative treatments for Wilson disease and advanced cancers.

On July 22, 2026, Monopar Therapeutics announced it initiated a rolling New Drug Application (NDA) submission to the FDA for ALXN1840 (tiomolibdate choline) for the treatment of Wilson disease. The FDA authorized a rolling submission, and the company has already submitted the first completed sections. ALXN1840 previously received Fast Track, Orphan Drug, and Rare Pediatric Disease designations in June 2026, the latter of which may grant the company a pediatric Priority Review Voucher upon approval. The drug's Phase 3 trial met its primary endpoint for copper mobilization over 48 weeks. Monopar Therapeutics is a clinical-stage biopharmaceutical company developing treatments for unmet medical needs, including Wilson disease and advanced cancers.

Monopar Therapeutics Inc. announced new analyses from its Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline) demonstrating greater neurologic and global clinical benefit compared to the standard of care in Wilson disease patients. The company will present these findings at the 12th Congress of the European Academy of Neurology (EAN) from June 27-30, 2026. Monopar Therapeutics Inc. is a biopharmaceutical company focused on developing therapeutic solutions for oncology and neurological diseases.