Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease

Monopar initiated a rolling New Drug Application submission to the FDA for ALXN1840 in Wilson disease, submitting initial completed sections.

Key Highlights:

• Monopar has begun a rolling NDA submission to the FDA for ALXN1840 (tiomolibdate choline) in Wilson disease.
• The FDA authorized rolling submission; Monopar has already submitted the first completed sections.
• ALXN1840 is a first-in-class albumin tripartite complex activator with Phase 3 data showing superior copper mobilization vs standard care.
• ALXN1840 holds Fast Track, Orphan Drug, and Rare Pediatric Disease designations, potentially enabling a pediatric Priority Review Voucher at approval.

Original SEC Filing:

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