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NewAmsterdam Pharma (NAMS/NAMSW) furnished an 8-K to disclose full Alzheimer’s disease (AD) biomarker data from the prespecified analysis of its Phase 3 BROADWAY LDL-C trial evaluating CETP inhibitor obicetrapib. In 1,727 patients (367 ApoE4 carriers) treated 12 months with 10 mg daily, obicetrapib produced a -2.99 % mean change in plasma p-tau217 vs. placebo (p = 0.019); effects intensified in genetic and age subgroups, reaching -20.48 % in ApoE4/E4 carriers (n = 29; p = 0.010). Statistically significant or favorable trends were also observed for NFL, GFAP, p-tau181 and Aβ42/40, biomarkers linked to neurodegeneration.
Safety was not analyzed separately but was stated to mirror the overall BROADWAY population, where obicetrapib was well-tolerated and comparable to placebo. The exploratory AD analysis was not adjusted for baseline differences. Results will be presented 30 July 2025 at AAIC; a company webcast will follow at 10:00 a.m. ET. Exhibits 99.1 (press release) and 99.2 (presentation) are furnished, with no financial statements included.
Douglas F. Kling, Chief Operating Officer of NewAmsterdam Pharma, reported significant insider transactions on June 16, 2025:
- Exercised stock options to acquire 100,000 total ordinary shares: - 78,101 shares at $10.00 per share - 21,899 shares at $10.90 per share
- Subsequently sold 100,000 shares in two tranches: - 81,891 shares at weighted average price of $19.19 - 18,109 shares at weighted average price of $19.75
- Post-transactions, Kling retains: - 44,000 ordinary shares - 372,829 options at $10.00 strike price - 261,314 options at $10.90 strike price
The transactions were executed under a Rule 10b5-1 trading plan. The sales represent a partial liquidation of Kling's holdings while maintaining significant equity exposure through remaining shares and options.