NewAmsterdam Pharma Highlights 2024 Achievements and Outlines 2025 Strategic Priorities

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, a CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease, with significant milestones expected in 2025 [1][2][12] Clinical Development - Positive topline results were announced for three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, which demonstrated safety profiles comparable to placebo and significant LDL-C reductions [2][3][4] - The BROADWAY trial showed a 33% reduction in LDL-C (p<0.0001) and a 21% reduction in major adverse cardiovascular events (MACE) [4][6] - The TANDEM trial achieved a 49% reduction in LDL-C (p<0.0001) with the obicetrapib-ezetimibe combination [7] - The BROOKLYN trial reported a 36% reduction in LDL-C (p<0.0001) [7] Regulatory and Intellectual Property - NewAmsterdam plans to submit global regulatory filings for obicetrapib, including EMA submission in the second half of 2025 [1] - The company has secured a new patent for obicetrapib, providing protection until July 2043 in the U.S., with a total of nine patents issued or allowed [5] Financial Position - The company reported an unaudited cash balance of $835 million at year-end 2024, following an oversubscribed public offering [1][9] - This financial strength is expected to support operations through the anticipated PREVAIL cardiovascular outcomes trial readout and potential commercial launch of obicetrapib [2] Future Plans - NewAmsterdam aims to present additional data from its Phase 3 studies and publish findings in high-impact journals throughout 2025 [6][8] - The company is also focused on commercial readiness, including scaling up manufacturing capacity and building inventory for potential U.S. and European launches [9]