Monopar Therapeutics 8K

Monopar Therapeutics initiated an FDA-authorized rolling NDA submission for ALXN1840 for Wilson disease, supported by positive Phase 3 data and rare disease regulatory designations that may yield a Priority Review Voucher upon approval.

On July 22, 2026, Monopar Therapeutics Inc. announced that it has initiated a rolling submission of a New Drug Application to the U.S. Food and Drug Administration for ALXN1840 (tiomolibdate choline, TMC), its first-in-class albumin tripartite complex activator for the treatment of Wilson disease, following FDA authorization to use a rolling NDA process and submission of the first completed sections. The company highlighted that, if the NDA is accepted for filing and ultimately approved, ALXN1840 could become the first U.S.-approved therapy with a novel mechanism of action for Wilson disease in decades, and noted that ALXN1840 has Fast Track, Orphan Drug, and Rare Pediatric Disease designations, the latter potentially qualifying Monopar for a pediatric Priority Review Voucher upon approval. The announcement also referenced positive pivotal Phase 3 clinical data, including meeting the primary endpoint with superior copper mobilization versus standard of care and a favorable safety profile across 645 patient-years in 266 patients.

Filing Facts

CIK

1645469

Ticker

MNPR

Form

8K

Source Type

fda

Accession

0001437749-26-024041

Alert Tier

7