---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-022086"
form_type: "8-K"
ticker: "MNPR"
cik: "0001645469"
company_name: "Monopar Therapeutics"
filed_at: "2026-06-30T12:00:16+00:00"
generated_at: "2026-06-30T12:05:37.755762+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Monopar receives FDA Rare Pediatric Disease designation for ALXN1840 in Wilson disease

## Summary
- FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline) for Wilson disease.
- RPD designation is for therapies treating serious/life-threatening diseases primarily affecting children under 18.
- Upon NDA approval, Monopar may receive a pediatric Priority Review Voucher (PRV).
- PRV can be used for priority review of a subsequent application or sold/transferred to another sponsor.
- CEO Chandler Robinson noted the designation underscores the serious impact of Wilson disease.

## SEC filing metadata
- accession: 0001437749-26-022086
- form_type: 8-K
- ticker: MNPR
- cik: 0001645469
- company_name: Monopar Therapeutics
- filed_at: 2026-06-30T12:00:16+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1645469/000143774926022086/0001437749-26-022086-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645469/000143774926022086/mnpr20260629_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-022086
- JSON: https://secwatch.observer/filing/0001437749-26-022086.json
- Plain text: https://secwatch.observer/filing/0001437749-26-022086.txt

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