other material
confidence high
sentiment positive
materiality 0.75
Monopar reports ALXN1840 shows significant neurologic and global benefit in Phase 3 FoCus trial
Monopar Therapeutics
- ALXN1840 achieved significant neurologic improvement on UWDRS Part III (p=0.006) vs SOC (p=0.435) over 48 weeks.
- Global clinical improvement on CGI-I at Week 48 significantly greater with ALXN1840 vs SOC (p<0.001).
- Favorable safety profile: drug-related SAEs in 4.9% of patients, no treatment-related deaths.
- Results support planned NDA submission to FDA for ALXN1840 in mid-2026.