Business
NewAmsterdam Pharma Highlights 2024 Achievements and Outlines 2025 Strategic Priorities
-- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025; expected to support global regulatory filings for obicetrapib,
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025; expected to support global regulatory filings for obicetrapib, including EMA submission in 2H25 by our partner Menarini – -- Data from Phase 2 VINCENT trial expected by 2H25, which explores effect of obicetrapib alone and in combination with a PCSK9i on Lp(a) – -- Focus on commercial readiness with manufacturing capacity establishment and inventory build-out -- -- Year end, unaudited, cash balance of $835 million following oversubscribed public offering in December 2024 -- NAARDEN, The Netherlands and MIAMI, Jan. 10, 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 provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2025. NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. The Company’s global, pivotal Phase 3 clinical development program consists of four trials in over 12,250 patients. \"2024 was a landmark year for NewAmsterdam, underscored by exceptional clinical and operational execution. We announced positive topline results from three pivotal Phase 3 trials, BROOKLYN, TANDEM, and BROADWAY, which will form the foundation for our planned global regulatory filings for obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We were particularly excited to announce results from BROADWAY, which demonstrated greater than expected reduction in the exploratory outcome measure of major adverse cardiovascular events (“MACE”) after only one year of treatment with obicetrapib, with a safety profile that was comparable to placebo. These data not only reinfor...