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NewAmsterdam Pharma Company N.V. reports news on its late-stage clinical biopharmaceutical work in oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C. The company’s principal program centers on obicetrapib, an oral, low-dose CETP inhibitor, evaluated alone and as a fixed-dose combination with ezetimibe as an adjunct to statin therapy.
Recurring updates include Phase 3 clinical data from programs such as BROADWAY, TANDEM, BROOKLYN and PREVAIL, safety and tolerability analyses, regulatory-review activity, financial results, corporate presentations and scientific-conference disclosures. NewAmsterdam also reports Nasdaq inducement grants and other equity-compensation actions tied to its public-company governance.
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NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 BROOKLYN clinical trial for obicetrapib, targeting adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels are inadequately managed despite maximal lipid-lowering therapy. The trial enrolled 354 participants across ten countries, with results expected in the second half of 2024. Obicetrapib, a next-generation CETP inhibitor, aims to offer improved options for HeFH patients. Previous Phase 2 trials showed significant LDL-C reduction of 51% and 59% in combination therapy. The rapid enrollment reflects a pressing unmet need for effective LDL-C management in the HeFH community.
NewAmsterdam Pharma Company (Nasdaq: NAMS) has announced the appointment of Janneke van der Kamp as an independent director on its Board of Directors. Ms. van der Kamp brings over two decades of pharmaceutical experience, particularly in cardiovascular disease. CEO Michael Davidson expressed optimism about her contributions as the company advances its clinical trials for obicetrapib. The company, focused on transforming therapies for metabolic diseases, is preparing for key regulatory milestones, building on promising clinical results showing significant LDL-C reductions with obicetrapib. NewAmsterdam recently completed a business combination with Frazier Lifesciences, raising approximately $328 million.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) has successfully completed its business combination with FLAC and raised approximately $235 million through an oversubscribed PIPE financing, extending its cash runway through 2026. The company announced positive results from the Phase 2 ROSE2 trial, showing a 59% reduction in LDL-C when obicetrapib was combined with ezetimibe, and is set to present full data at the NLA Scientific Sessions in June 2023. Additionally, NewAmsterdam has initiated a Phase 2 study in Japan and is on track with three pivotal Phase 3 trials for obicetrapib. As of December 31, 2022, the company reported €439 million in cash and €98 million in revenue.
NewAmsterdam Pharma Company, a clinical-stage firm focused on cardiometabolic diseases, announced CEO Michael Davidson’s participation in the Cowen 43rd Annual Health Care Conference on March 7 and 8, 2023. Davidson will discuss cardiovascular therapies and present the company's innovations. NewAmsterdam is developing obicetrapib, an oral CETP inhibitor, aimed at reducing LDL-C levels in high-risk cardiovascular patients. Previous trials, including ROSE and ROSE2, showed significant LDL-C reductions with obicetrapib. The company recently completed a $328 million business combination with Frazier Lifesciences and secured licensing rights for obicetrapib in Europe.
NewAmsterdam Pharma Company announced that Michael Davidson, M.D., CEO, will present at the SVB Securities Global Biopharma Conference on February 16, 2023, at 1:00 p.m. ET. The presentation can be accessed live via the investor relations section of their website with an archived replay available later.
The company focuses on developing oral therapies for cardiometabolic diseases. Its lead candidate, obicetrapib, has shown promising Phase 2b trial results, achieving a median 51% reduction in LDL-C levels in high-risk cardiovascular patients. Recently, NewAmsterdam completed a business combination with Frazier Lifesciences, securing around $328 million in proceeds to further its development efforts.