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On July 22, 2026, Monopar Therapeutics announced it initiated a rolling New Drug Application (NDA) submission to the…
MNPRMonopar Therapeutics
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.