Monopar starts rolling FDA NDA submission for ALXN1840 in Wilson disease
MNPR•Rolling NDA submission begins
Monopar Therapeutics initiated a rolling NDA submission to the FDA for ALXN1840 in Wilson disease.
The FDA authorized the rolling review; initial NDA sections have already been submitted.
Rare Pediatric Disease designation
ALXN1840 received FDA Rare Pediatric Disease designation in June 2026, supporting eligibility for a pediatric priority review voucher at approval.
