regulatory
confidence high
sentiment positive
materiality 0.75
Monopar initiates rolling NDA submission for ALXN1840 in Wilson disease
Monopar Therapeutics
- Rolling NDA submission started; first completed sections submitted to FDA.
- ALXN1840 is a first-in-class albumin tripartite complex activator for Wilson disease.
- FDA granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations.
- Rare Pediatric Disease designation could yield a Priority Review Voucher upon NDA approval.
- If approved, would be first novel mechanism therapy for Wilson disease in decades.