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Jun 30, 2024
NewAmsterdam Pharma Q2 2024 Earnings Report
NewAmsterdam Pharma reported positive topline data from pivotal Phase 3 BROOKLYN trial and extended US IP protection into 2043.
Key Takeaways
NewAmsterdam Pharma reported positive results from its Phase 3 BROOKLYN trial, extended its US IP protection for obicetrapib into 2043, and has a strong cash position of $430.7 million. Topline data from the BROADWAY trial is expected in Q4 2024, and the TANDEM trial data is expected in Q1 2025.
Positive topline data from the Phase 3 BROOKLYN trial, with obicetrapib achieving a statistically significant reduction in LDL-C compared to placebo.
US IP protection extended into 2043 with a new composition of matter patent.
Topline data from the Phase 3 BROADWAY trial is expected in the fourth quarter of 2024.
Completed enrollment of the Phase 3 TANDEM trial, with topline data expected in the first quarter of 2025.
Forward Guidance
NewAmsterdam Pharma anticipates announcing full data from the Phase 3 BROOKLYN trial at an upcoming medical conference and publishing the data in a major medical journal. Topline data from the Phase 3 BROADWAY trial is expected in the fourth quarter of 2024, and topline data from the Phase 3 TANDEM trial is expected in the first quarter of 2025.
Positive Outlook
- Announce full data from Phase 3 BROOKLYN trial for obicetrapib monotherapy at an upcoming medical conference.
- Publish the data from the Phase 3 BROOKLYN trial in a major medical journal.
- Announce topline data from the Phase 3 BROADWAY trial for obicetrapib monotherapy in the fourth quarter of 2024.
- BROADWAY is evaluating obicetrapib in adult patients with HeFH and/or established ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
- Announce topline data from the Phase 3 TANDEM trial evaluating a FDC of obicetrapib and ezetimibe in the first quarter of 2025.
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