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NAARDEN, The Netherlands - NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS), a clinical biopharmaceutical company valued at $2.26 billion, today announced positive results from a sub-study of its Phase 3 BROADWAY trial, showing significant reductions in Alzheimer’s disease biomarkers. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for continued research and development. The study focused on the effects of obicetrapib, a cholesterol ester transfer protein (CETP) inhibitor, in lowering biomarkers associated with Alzheimer’s disease progression.
The BROADWAY trial primarily aimed to assess obicetrapib’s efficacy in lowering low-density lipoprotein cholesterol (LDL-C) in patients with cardiovascular disease or familial hypercholesterolemia. Within this trial, a pre-specified sub-study evaluated the impact of obicetrapib on Alzheimer’s disease plasma biomarkers over a 12-month period, particularly in patients carrying the ApoE4 gene variant associated with an increased risk of Alzheimer’s.
Statistically significant reductions in the primary outcome measure of the Alzheimer’s biomarker p-tau217 were observed in the full intention-to-treat population (p
The sub-study included 1,727 patients, with 367 being ApoE4 carriers. The trial also monitored additional biomarkers such as neurofilament light chain and glial fibrillary acidic protein. The full results of the Alzheimer’s sub-study are slated to be presented at the Alzheimer’s Association International Conference in Toronto at the end of July 2025.
The safety profile of obicetrapib has been established across multiple clinical trials, with side effects similar to placebo. NewAmsterdam’s Chief Executive Officer, Michael Davidson, M.D., emphasized the potential of CETP inhibition in reducing the risk of Alzheimer’s disease progression. InvestingPro analysis shows that five analysts have revised their earnings estimates upward for the upcoming period, reflecting growing confidence in the company’s development pipeline. The company maintains a healthy current ratio of 19.98, indicating strong ability to meet short-term obligations. The company’s Chief Scientific Officer, John Kastelein, M.D., Ph.D., highlighted the broader implications of obicetrapib in addressing chronic cardiometabolic disease and neurodegeneration.
The Phase 3 BROADWAY trial was a global, randomized, double-blind, placebo-controlled multicenter trial, including over 2,500 patients. The trial’s primary endpoint was the percent change from baseline in LDL-C after 84 days, with obicetrapib showing a 33% reduction.
These results are based on a press release statement and reflect the company’s ongoing research into obicetrapib as a potential treatment for both cardiovascular and neurodegenerative diseases. While the company reported significant revenue growth of 587% in the last twelve months, InvestingPro data indicates it is not yet profitable, with analysts anticipating continued investment in research and development. For deeper insights into NAMS’s financial health, valuation metrics, and growth potential, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 7 additional ProTips and extensive financial metrics.
In other recent news, NewAmsterdam Pharma Company has reported significant developments related to its lead drug, obicetrapib. The company announced additional data from its Phase 3 studies, BROADWAY and TANDEM, indicating that obicetrapib, when used with statins, significantly reduces LDL cholesterol levels and potentially lowers major adverse cardiovascular events. The BROADWAY trial showed a 33% reduction in LDL-C, while the TANDEM trial demonstrated a 48.6% reduction. Furthermore, the drug has been well-tolerated, with a safety profile comparable to placebo.
Cantor Fitzgerald has initiated an Overweight rating for NewAmsterdam Pharma, with a 12-month price target of $42, highlighting the potential of obicetrapib, which is undergoing a pivotal Phase 3 trial known as PREVAIL. RBC Capital also maintained its Outperform rating, setting a price target of $38, and projected U.S. sales for obicetrapib between $1.6 billion and $2.7 billion. The company has also welcomed Adele Gulfo to its Board of Directors, bringing her extensive experience in pharmaceutical commercialization to the table. These developments reflect NewAmsterdam Pharma’s strategic efforts to advance obicetrapib’s market presence and address unmet needs in cardiovascular treatment.
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