secwatch.observer — SEC 8-K summary
======================================

Issuer:     Monopar Therapeutics (MNPR)
CIK:        0001645469
Form:       8-K
Filed at:   2026-04-20T23:59:59+00:00
Accession:  0001437749-26-012751
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Monopar Phase 3 ALXN1840 data shows greater neurologic benefit vs SoC in Wilson disease
--------------------------------------------------------------------------------

- Neurologic worsening at Week 48: 9% ALXN1840 vs 25% SoC (p=0.038); improvement 45% vs 32%.
- CGI-S improvement from baseline to Week 48: 61% ALXN1840 vs 17% SoC (p=0.008); CGI-I 47% vs 19% (p=0.003).
- Durable neurologic benefit over ~3 years in long-term follow-up; consistent across treatment-naïve and experienced.
- Safety: drug-related SAEs 4.9%; neurologic SAEs <1%; no treatment-related deaths.
- NDA submission to FDA planned for mid-2026 based on these results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1645469/000143774926012751/0001437749-26-012751-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1645469/000143774926012751/mnpr20260419_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-012751

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer