NAARDEN, The Netherlands – NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS), a clinical-stage biopharmaceutical company with a market capitalization of $1.7 billion, today announced positive topline results from its Phase 3 BROADWAY clinical trial, evaluating its drug candidate obicetrapib in patients with cardiovascular disease (CVD). According to InvestingPro data, the company's stock has delivered an impressive 89% return over the past year, reflecting strong investor confidence in its development pipeline.
The study met its primary endpoint, demonstrating a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels compared to placebo at day 84. The results showed a 33% decrease in LDL-C levels with obicetrapib, a notable outcome considering patients were already on maximally tolerated lipid-lowering therapies.
Additionally, a 21% reduction in major adverse cardiovascular events (MACE) was observed in the obicetrapib arm compared to placebo at one year, although MACE was not a primary or secondary endpoint of the trial. This finding suggests a potential for obicetrapib to offer cardiovascular risk reductions beyond LDL-C lowering. While the company maintains a strong financial position with a current ratio of 10.61 and minimal debt, InvestingPro analysis indicates it is not yet profitable, with analysts anticipating continued losses this year. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis for NAMS.
The safety profile of obicetrapib was comparable to that of the placebo, with similar rates of treatment discontinuation and adverse events. The trial also monitored glycemic control and renal function, which reportedly favored obicetrapib.
NewAmsterdam plans to present more detailed data from the BROADWAY trial at a future medical conference and to publish the findings in a leading medical journal. The company also intends to discuss regulatory filings for obicetrapib with authorities in 2025.
The BROADWAY trial, part of a larger Phase 3 program, involved over 2,500 patients and focused on the efficacy and safety of obicetrapib as an adjunct to existing lipid-lowering treatments. The trial's design included a 52-week period, with a 2:1 randomization of patients receiving either obicetrapib or placebo. With analyst price targets ranging from $29.52 to $50.22, and an overall Financial Health Score of "FAIR" from InvestingPro, investors can access detailed valuation metrics and comprehensive research reports through the platform's premium features.
Obicetrapib is an oral, once-daily, low-dose CETP inhibitor developed as a non-statin alternative for patients at risk of CVD with elevated LDL-C. The drug has shown promise in previous Phase 2 and Phase 3 trials, with significant LDL-lowering effects and a side effect profile similar to placebo.
This announcement is based on a press release statement from NewAmsterdam Pharma Company N.V.
In other recent news, NewAmsterdam Pharma Co NV has been in the spotlight following promising Phase 3 TANDEM trial results for its drug candidate, obicetrapib. The trial demonstrated a significant 48.6% reduction in LDL-C levels compared to placebo, exceeding expectations. Leerink Partners, in response to this development, raised their price target for the company to $45, maintaining an Outperform rating. Notably, Piper Sandler and TD Cowen also maintained positive ratings for the company.
The company's recent developments also include the restatement of its financial statements for the years ending 2022 and 2021 due to identified errors in the calculation of net loss per ordinary share. NewAmsterdam Pharma also welcomed new board members, Mark C. McKenna and Wouter Joustra.
Looking ahead, the company is preparing for the Phase 3 BROADWAY trial readout, expected in the fourth quarter of 2024, and the Phase 3 HORIZON trial of pelacarsen in 2025. Piper Sandler anticipates these upcoming events could significantly impact the company's trajectory. These are the recent developments for NewAmsterdam.
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