ALXN1840 (WTX101) - (FoCus)

July 22, 2026: Monopar Therapeutics Inc. (NASDAQ: MNPR) announced it has initiated a rolling New Drug Application (NDA) submission to the U.S. FDA for ALXN1840 (tiomolibdate choline; TMC), an investigational first-in-class albumin tripartite complex (ATC) activator for Wilson disease. The FDA has authorized rolling review, and Monopar has submitted the first completed sections; the NDA is still pending FDA filing acceptance and review.

The company noted ALXN1840 has Fast Track and Orphan Drug designations and received FDA Rare Pediatric Disease designation in June 2026, which could enable a pediatric Priority Review Voucher upon NDA approval.

Clinical support cited includes a pivotal Phase 3 trial in which ALXN1840 met its primary endpoint, showing rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and treatment-naïve patients. Monopar also reported durable clinical improvement and favorable tolerability across 645 patient-years of follow-up in 266 patients.

Monopar also referenced its radiopharmaceutical pipeline: MNPR-101-Zr (Phase 1 imaging), MNPR-101-Lu (Phase 1a treatment), and MNPR-101-Ac (late preclinical) for advanced cancers.