The rolling NDA submission for ALXN1840 is the primary catalyst. Monitor for completion of the NDA submission within the next few months and FDA acceptance for filing. The Rare Pediatric Disease designation adds potential PRV value. Cash runway through 2027 eliminates near-term dilution risk.
Price Chart
Executive Summary
Monopar Therapeutics reported a Q2 2026 net loss of $5.3M ($0.62/share), wider than the $2.5M loss in Q2 2025, driven by increased R&D spending on ALXN1840 NDA preparation and commercial readiness. The key catalyst is the ongoing rolling NDA submission for ALXN1840 in Wilson disease, with Rare Pediatric Disease designation providing potential for a Priority Review Voucher. Cash of $134.3M funds operations through at least December 2027, removing near-term financing risk for this pre-revenue biotech.
Key Financial Metrics
Key Facts
- Q2 2026 net loss $5.3M ($0.62/share) vs $2.5M ($0.35/share) in Q2 2025
- Cash, cash equivalents and investments $134.3M as of June 30, 2026
- R&D expenses $4.77M in Q2 2026 vs $1.73M in Q2 2025, driven by ALXN1840 NDA preparation
- Rolling NDA submission for ALXN1840 in Wilson disease initiated July 22, 2026
- FDA granted Rare Pediatric Disease designation to ALXN1840 on June 30, 2026
- Cash runway through at least December 2027
- EPS of -$0.62 vs consensus -$0.65 (4.6% beat)
Financial Impact
Net loss widened $2.8M YoY; cash burn $5.3M/quarter; $134.3M cash provides ~4+ years runway
Risk Factors
- FDA may not accept NDA for filing or may not approve ALXN1840
- PRV program may be discontinued or voucher value may be lower than expected
- Commercial launch execution risk for a first-in-class therapy in a rare disease
- Pre-revenue company with no approved products; relies on capital markets for funding beyond 2027
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3343777 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | Institutional Cluster | $72.00 | awaiting T+60 | — | $71.84 (−0.22%) |
Oct 27, 2026 today | SC 13G | $72.00 | awaiting T+60 | — | $71.84 (−0.22%) |
Oct 5, 2026 22d ago | Insider Cluster | $79.57 | awaiting T+60 | — | $71.84 (+9.71%) |
Oct 1, 2026 26d ago | 144 | $77.97 | awaiting T+60 | — | $71.84 (−7.86%) |
Aug 28, 2026 8w ago | Insider Cluster | $111.93 | awaiting T+60 | — | $71.84 (−35.82%) |
Aug 27, 2026 8w ago | Insider Cluster | $111.89 | awaiting T+60 | — | $71.84 (−35.79%) |
Aug 25, 2026 9w ago | 144 | $113.72 | awaiting T+60 | — | $71.84 (−36.83%) |
Aug 12, 2026 10w ago | 8-K | $114.90 | awaiting T+60 | — | $71.84 (−37.48%) |
Aug 12, 2026 10w ago | Press Release | $114.90 | awaiting T+60 | — | $71.84 (−37.48%) |
Jul 22, 2026 13w ago | 8-K | $112.48 $71.80 | ▼ −36.17% | ▼ −39.43% | $71.84 (−36.13%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers