other material
confidence high
sentiment positive
materiality 0.75
Monopar Phase 3 ALXN1840 data shows greater neurologic benefit vs SoC in Wilson disease
Monopar Therapeutics
- 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.