Quarterly ResultAug 5, 2026, 07:12 AM
NewAmsterdam Pharma Gets Positive CHMP Opinion; Q2 Net Loss $64.1M
AI Summary
NewAmsterdam Pharma announced a positive CHMP opinion recommending marketing authorization for obicetrapib and its fixed-dose combination in Europe, a significant regulatory milestone. The company also provided updates on its clinical pipeline, including planned interim analysis for PREVAIL in Q4 2026 and topline data for RUBENS by year-end 2026. Financially, the company reported $678.3 million in cash, cash equivalents, and marketable securities as of June 30, 2026. Revenue for the second quarter was $3.7 million, with a net loss of $64.1 million, reflecting increased R&D investments.
Key Highlights
- CHMP recommended marketing authorization for obicetrapib and obicetrapib/ezetimibe in Europe.
- PREVAIL interim analysis planned for Q4 2026, results expected Q1 2027.
- RUBENS Phase 3 topline data expected by year-end 2026.
- Cash, cash equivalents, and marketable securities totaled $678.3M as of June 30, 2026.
- Revenue for Q2 2026 was $3.7M, down from $19.1M in Q2 2025.
- Net loss for Q2 2026 was $64.1M, compared to $17.4M in Q2 2025.
- R&D expenses increased to $41.7M in Q2 2026 from $27.5M in Q2 2025.
Price Impact
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