earnings
confidence high
sentiment positive
materiality 0.80
Monopar Q2 net loss $5.3M; initiates rolling NDA for ALXN1840
Monopar Therapeutics
- Net loss $5.3M ($0.62/share) vs $2.5M ($0.35) in Q2 2025; R&D spend $4.77M (up from $1.73M).
- Cash and investments $134.3M as of June 30, 2026; runway through at least Dec 31, 2027.
- Rolling NDA submission to FDA for ALXN1840 initiated July 22, 2026; RPD designation granted June 30, 2026.
- RPD designation supports potential pediatric Priority Review Voucher at NDA approval; commercial team added.
- Positive Phase 3 FoCus data presented at EAN 2026 and AAN 2026 showing neurologic benefit vs standard of care.