NAARDEN, The Netherlands – NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS), a clinical-stage biopharmaceutical firm with a market capitalization of $2.7 billion, is preparing for global regulatory submissions of its cholesterol-lowering drug candidate, obicetrapib, following a strong financial position reported at the end of the previous year. The company, which focuses on non-statin therapies for cardiovascular disease (CVD) patients with high low-density lipoprotein cholesterol (LDL-C), announced an unaudited cash balance of $835 million after a successful public offering in December 2024. According to InvestingPro data, the stock has shown remarkable strength, trading near its 52-week high with a 48% return over the past year.
The company’s chief executive, Michael Davidson, M.D., highlighted 2024 as a pivotal year, with positive topline results from three Phase 3 trials—BROADWAY, TANDEM, and BROOKLYN—setting the stage for the anticipated regulatory filings. Notably, the BROADWAY study showed a significant reduction in major adverse cardiovascular events (MACE) with a safety profile comparable to placebo. InvestingPro analysis shows the company maintains strong financial health with a current ratio of 10.6, indicating robust liquidity to support its clinical development programs.
NewAmsterdam plans to unveil additional data from these studies throughout 2025. It also aims to present findings at medical conferences and in high-impact journals, particularly from the ongoing PREVAIL Phase 3 cardiovascular outcomes trial, which seeks to confirm the MACE benefit of obicetrapib.
The company is also conducting the VINCENT Phase 2 trial, expected to conclude in the second half of 2025, and the REMBRANDT Phase 3 imaging trial, set to complete in 2027. These studies will further evaluate obicetrapib’s effects on cardiovascular health indicators.
With a focus on commercial readiness, NewAmsterdam is establishing manufacturing capacity and inventory build-out to support the U.S. and European launches of obicetrapib, pending approval.
Obicetrapib is a novel CETP inhibitor developed to address the limitations of current LDL-lowering treatments. The company has been granted commercialization rights for obicetrapib in Europe by the Menarini Group.
Despite advancements in lipid-lowering therapies, CVD remains the leading cause of death globally, with a significant number of patients not achieving LDL-C targets, underscoring the need for more effective treatments. NewAmsterdam’s strategic priorities for 2025 are aligned with its mission to improve care for patients with metabolic diseases. While analysts project continued losses this year, InvestingPro subscribers can access detailed financial forecasts and 11 additional ProTips that provide deeper insights into the company’s potential. Get the complete analysis with InvestingPro’s comprehensive research report, available for over 1,400 US stocks.
This article is based on a press release statement from NewAmsterdam Pharma Company N.V.
In other recent news, NewAmsterdam Pharma Co NV has made significant strides in its recent clinical trials. The company’s leading drug candidate, obicetrapib, has demonstrated impressive results in Phase 3 trials, showing a considerable reduction in LDL-C cholesterol levels and a 21% decrease in major adverse cardiovascular events. H.C. Wainwright initiated coverage on NewAmsterdam, issuing a Buy rating, highlighting obicetrapib’s potential to revolutionize cholesterol management. Scotiabank (TSX:) and Leerink Partners have also upgraded their price targets for NewAmsterdam, following these positive developments.
The company has also announced the suspension and termination of its previously filed Automatic Teller Machine (ATM) Prospectus related to a $150 million share sale plan. Additionally, NewAmsterdam has restated its financial statements for the years ending 2022 and 2021 due to identified errors in the calculation of net loss per ordinary share. New board members, Mark C. McKenna and Wouter Joustra, have joined the company.
These are recent developments that have been shaping the trajectory of NewAmsterdam Pharma. The company is now preparing for the Phase 3 HORIZON trial of pelacarsen in 2025 and the Phase 3 BROADWAY trial readout, expected in the fourth quarter of 2024.
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