Monopar Starts Rolling Wilson Disease Drug Application
The drug candidate received Rare Pediatric Disease designation in June 2026.
Monopar Therapeutics (MNPR), the drug developer, initiated a rolling new drug application submission for ALXN1840 in Wilson disease.
The move advanced ALXN1840 into the application process after the Food and Drug Administration authorized rolling review.
Monopar submitted the first completed sections of the application, allowing the FDA review process to begin before the full submission was assembled.
The regulatory step marked the central development for the company during the period, with no prior-quarter comparison provided.
ALXN1840 also received Rare Pediatric Disease designation from the FDA in June 2026.
That designation creates the potential for a pediatric Priority Review Voucher if ALXN1840 receives approval, leaving the incentive contingent on the FDA’s ultimate decision.