USFDAAug 12, 2026, 09:32 AM
Monopar Initiates Rolling NDA for ALXN1840; Reports Q2 2026 Results
AI Summary
Monopar Therapeutics announced the initiation of a rolling New Drug Application (NDA) submission to the FDA for ALXN1840 for Wilson Disease, following the grant of Rare Pediatric Disease (RPD) designation. The company also reported positive Phase 3 and Phase 2 clinical trial data for ALXN1840 and strengthened its commercial readiness team. For the second quarter of 2026, Monopar reported a net loss of $5.3 million and held $134.3 million in cash, cash equivalents, and investments, expected to fund operations through at least December 2027.
Key Highlights
- Initiated rolling NDA submission to FDA for ALXN1840 for Wilson Disease on July 22, 2026.
- FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 on June 30, 2026.
- Cash, cash equivalents, and investments were $134.3 million as of June 30, 2026.
- Net loss for Q2 2026 was $5.3 million, or $0.62 per share, vs. $2.5 million in Q2 2025.
- R&D expenses increased to $4.77 million in Q2 2026 from $1.73 million in Q2 2025.
- G&A expenses increased to $1.88 million in Q2 2026 from $1.50 million in Q2 2025.
- Interest income was $1.30 million in Q2 2026, up from $0.78 million in Q2 2025.
Price Impact
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