Monopar Therapeutics Begins Rolling Submission Of FDA New Drug Application For ALXN1840 Albumin Tripartite Complex Activator To Treat Wilson Disease

The FDA has authorized Monopar to submit the NDA on a rolling basis, allowing completed sections of the application to be submitted and reviewed while the Company finalizes the remaining sections. Monopar has submitted the first completed sections of the NDA.

If the completed NDA is accepted for filing and subsequently approved, ALXN1840 would be the first therapy with a novel mechanism of action approved in the United States for Wilson disease in decades.

In addition to Fast Track and Orphan Drug designations, ALXN1840 received Rare Pediatric Disease ("RPD") designation by the FDA in June 2026. The RPD designation provides the Company with the potential, at the time of NDA approval, to receive a pediatric Priority Review Voucher ("PRV").