Business
NewAmsterdam Pharma Reports Full Year 2024 Financial Results and Provides Corporate Update
-- EMA submission expected in 2H25 by partner Menarini -- -- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025 -- -- Phase 3
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- EMA submission expected in 2H25 by partner Menarini -- -- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025 -- -- Phase 3 PREVAIL CVOT remains on track -- -- $834.2 million in cash, cash equivalents and marketable securities at December 31, 2024 -- NAARDEN, the Netherlands and MIAMI, Feb. 26, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the full year ended December 31, 2024 and provided a corporate update. \"2024 was a transformative year for NewAmsterdam, marked by compelling data from three pivotal Phase 3 trials – BROOKLYN, TANDEM, and BROADWAY – where we observed durable LDL-C lowering by obicetrapib for CVD patients. In 2025, we look forward to sharing additional data and insights from these trials, including the impact of obicetrapib on the exploratory endpoint of major adverse cardiac events (“MACE”), at leading medical meetings and journal publications, as well as advancing regulatory interactions, including an anticipated EMA submission in the second half by our partner Menarini,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Additionally, we are increasing focus and efforts around launch readiness with plans to scale up and build inventory and commercial capabilities sufficient to support the launch of obicetrapib in both the U.S. and Europe, if approved. Following our successful $479 million upsized financing in December, we have the necessary capital to fund operations beyond the PREVAIL cardiovascular outcomes trial (“CVOT”) readout and commercial launch of obicetrapib in the U.S., pending regulatory approval. We are excited to build on the strong momentum from the past year, as we work diligently to deliver a potentially transformative therapy to millions of CVD patients globally,” continued Dr. Davidson. Clinical Development Updates NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, a...