New cholesterol drug shows promise in clinical trials

Published 07/05/2025, 12:22
New cholesterol drug shows promise in clinical trials

NAARDEN, The Netherlands - NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS), a clinical biopharmaceutical company with a market capitalization of $2.09 billion, has announced additional data from its BROADWAY and TANDEM Phase 3 studies of obicetrapib, an oral medication aimed at reducing low-density lipoprotein cholesterol (LDL-C) for cardiovascular disease (CVD) patients. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet and a healthy current ratio of 8.08. The results, presented at the European Atherosclerosis Society Congress (EAS) 2025, indicate that obicetrapib, used alongside statins, could significantly lower LDL-C levels and potentially reduce major adverse cardiovascular events (MACE).

The BROADWAY trial, now published in The New England Journal of Medicine, showed that obicetrapib achieved a primary endpoint with a 33% reduction in LDL-C compared to placebo. Additionally, an exploratory safety analysis indicated a 21% relative reduction in MACE. The TANDEM trial, published in The Lancet, evaluated a fixed-dose combination of obicetrapib and ezetimibe, demonstrating a 48.6% LDL-C reduction compared to placebo. While the company is not yet profitable, InvestingPro analysis shows impressive revenue growth of 223% in the last twelve months, suggesting strong commercial potential. Get deeper insights into NAMS’s financial health and growth prospects with InvestingPro’s comprehensive research report, available along with 6 additional ProTips.

Beyond LDL-C reduction, pooled data from the BROADWAY, TANDEM, and BROOKLYN trials suggest a 45% reduction in lipoprotein(a), a contributor to residual cardiovascular risk. The TANDEM trial also reported that over 60% of patients achieved LDL-C levels below 55 mg/dL, a notable finding for CVD management.

Obicetrapib has been observed to be well-tolerated with a safety profile comparable to placebo. This data supports the drug’s potential as an effective, once-daily oral treatment adjunctive to statins for patients with elevated LDL-C who do not respond sufficiently to existing therapies.

The Company’s ongoing PREVAIL cardiovascular outcomes trial, which completed enrollment in April 2024, is designed to assess the potential of obicetrapib to reduce occurrences of MACE further. The commercialization rights of obicetrapib in Europe have been granted to the Menarini Group.

Despite advancements in lipid-lowering therapies, achieving LDL-C goals remains a challenge for many patients, with CVD mortality rates on the rise. NewAmsterdam’s development of obicetrapib reflects a commitment to addressing this unmet clinical need. Analysts maintain a bullish outlook on the company’s prospects, with price targets ranging from $38.84 to $56.14, significantly above the current trading price of $19. For comprehensive analysis of NAMS and other biotech companies, explore InvestingPro’s extensive financial metrics and expert insights.

This report is based on a press release statement and provides a summary of the latest findings without promotion or endorsement of claims. The information focuses on the potential of obicetrapib to improve patient care in populations with metabolic diseases where current therapies are inadequate or poorly tolerated.

In other recent news, NewAmsterdam Pharma has announced the appointment of Adele Gulfo to its Board of Directors. Gulfo brings over 30 years of experience in the pharmaceutical industry and has been involved in the commercialization of major medications. Her appointment comes as the company is preparing for the potential launch of its new drug candidate, obicetrapib, in the upcoming year. In addition to this, Scotiabank has raised its price target for NewAmsterdam Pharma to $52, up from $47, and maintained a Sector Outperform rating. The increase is attributed to the effectiveness of obicetrapib, as demonstrated by three Phase 3 trials, and the company’s solid financial position with $834 million in cash. Scotiabank anticipates that NewAmsterdam Pharma’s strong trial results and financial health could position it for a potential acquisition. Furthermore, the extension of the composition of matter intellectual property for obicetrapib to 2043 enhances its commercial prospects. These developments suggest that NewAmsterdam Pharma is well-positioned as it moves toward regulatory filings and commercialization efforts.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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