---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-024041"
form_type: "8-K"
ticker: "MNPR"
cik: "0001645469"
company_name: "Monopar Therapeutics"
filed_at: "2026-07-22T12:00:09+00:00"
generated_at: "2026-07-22T12:05:13.058598+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Monopar initiates rolling NDA submission for ALXN1840 in Wilson disease

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-26-024041
- form_type: 8-K
- ticker: MNPR
- cik: 0001645469
- company_name: Monopar Therapeutics
- filed_at: 2026-07-22T12:00:09+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1645469/000143774926024041/0001437749-26-024041-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645469/000143774926024041/mnpr20260721_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-024041
- JSON: https://secwatch.observer/filing/0001437749-26-024041.json
- Plain text: https://secwatch.observer/filing/0001437749-26-024041.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.