NewAmsterdam Pharma Company N.V Stock Price, News & Analysis

NewAmsterdam Pharma (NASDAQ:NAMS) announced that the European Medicines Agency (EMA) has validated Marketing Authorization Applications for obicetrapib, both as a 10mg monotherapy and as a fixed-dose combination with ezetimibe. The applications, submitted by partner Menarini, target adults with primary hypercholesterolemia or mixed dyslipidemia.

The submissions are supported by three pivotal Phase 3 trials: BROADWAY, BROOKLYN, and TANDEM, which demonstrated LDL-C reductions of 35-40% for obicetrapib monotherapy and approximately 50% when combined with ezetimibe versus placebo. Under the partnership agreement, NewAmsterdam is eligible for up to €833 million in milestone payments and tiered double-digit royalties ranging from low double-digits to mid-twenties on net sales in Menarini's territory.

NewAmsterdam Pharma (NASDAQ: NAMS) reported Q2 2025 financial results and provided updates on its lead candidate obicetrapib. The company ended Q2 with $783.3 million in cash, reporting revenue of $19.1 million and a net loss of $17.4 million.

Key clinical developments include positive data from the BROADWAY and TANDEM trials, published in The New England Journal of Medicine and The Lancet respectively. Notably, BROADWAY's Alzheimer's disease analysis showed obicetrapib significantly reduced plasma p-tau217 levels versus placebo, with a 20.5% reduction in ApoE4/E4 carriers.

The company's European marketing authorization application is on track for 2H25, while the PREVAIL Phase 3 cardiovascular outcomes trial continues with over 9,500 patients enrolled. NewAmsterdam is also preparing to launch the Phase 3 RUBENS trial to evaluate obicetrapib with ezetimibe in type 2 diabetes patients.

NewAmsterdam Pharma (NASDAQ: NAMS) has announced positive data from its BROADWAY trial, demonstrating significant reductions in Alzheimer's disease biomarkers. The trial showed that obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's biomarker, in both the full analysis set (p=0.0019) and ApoE4 carriers (p=0.0215).

Most notably, in APOE4/E4 carriers, who face the highest risk for Alzheimer's, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo (p=0.010). The study included 1,515 patients, with 367 being ApoE4 carriers. Additional biomarkers including NFL, GFAP, p-tau181, and Aβ42/40 ratio also showed favorable trends, particularly in carriers of two E4 proteins.

These results complement obicetrapib's established cardiometabolic benefits, suggesting potential as a dual-action therapy for both cardiovascular and neurodegenerative conditions.

NewAmsterdam Pharma (Nasdaq: NAMS) announced it will present comprehensive Alzheimer's Disease (AD) biomarker data from its BROADWAY clinical trial at the Alzheimer's Association International Conference (AAIC) on July 30, 2025 in Toronto.

The presentation will focus on the effects of Obicetrapib, an oral CETP inhibitor, on Alzheimer's Disease biomarkers in 1,727 patients with cardiovascular disease. The company will host a webcast at 10:00 a.m. ET featuring distinguished speakers including Dr. Philip Scheltens, Dr. Kellyann Niotis, and Dr. Nathaniel Chin to discuss the findings.

NewAmsterdam Pharma (NAMS) announced positive topline data from their Phase 3 BROADWAY trial's Alzheimer's Disease sub-study for obicetrapib. The study demonstrated statistically significant reductions in Alzheimer's disease biomarkers, particularly p-tau217, in both the general population (p<0.002) and ApoE4 carriers (p=0.0215) over 12 months. The sub-study included 1,727 patients, with 367 ApoE4 carriers. The BROADWAY trial primarily evaluated obicetrapib's effectiveness in lowering LDL-C in patients with ASCVD and/or HeFH. The study involved 2,530 patients randomized 2:1 to receive 10mg obicetrapib or placebo. A separate Phase 2a trial in early AD patients showed reductions in cholesterol markers in plasma and cerebrospinal fluid, with favorable safety results.

NewAmsterdam Pharma (NAMS), a clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with high LDL-C levels, has announced an R&D Day event scheduled for June 11, 2025, at 9:00 a.m. ET in New York City. The event will feature presentations from key management team members including CEO Michael Davidson, Founder and CSO John Kastelein, CCO BJ Jones, CFO Ian Somaiya, and EVP Matthew Philippe. Investors and analysts can attend either in person (with required pre-registration) or virtually through a live webcast. The presentation materials will be available on the company's investor relations website, with an archived replay accessible after the event.

NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage biopharma company developing oral, non-statin medicines for cardiovascular disease patients, announced its participation in three major investor conferences in June 2025:

1. William Blair Growth Stock Conference (Chicago) - June 3, featuring CEO Michael Davidson presenting a corporate overview at 3:20 PM CT

2. Jefferies Global Healthcare Conference (New York) - June 4, with CFO Ian Somaiya in a fireside chat at 10:30 AM ET

3. Goldman Sachs Healthcare Conference (Miami) - June 9, featuring CEO Michael Davidson and EVP Matthew Phillipe in a fireside chat at 2:40 PM ET

Live webcasts will be available through NewAmsterdam's investor relations website, with archived replays accessible afterward.

NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with elevated LDL-C, has announced its participation in the 2025 RBCCM Global Healthcare Conference. Ian Somaiya, the company's Chief Financial Officer, will engage in a fireside chat on Tuesday, May 20, 2025, at 10:00 a.m. ET. The presentation will be accessible via live webcast through NewAmsterdam's investor relations website, with an archived replay available afterward.

NewAmsterdam Pharma (NAMS) reported Q1 2025 financial results and corporate updates. The company ended Q1 with $808.5 million in cash and equivalents, down from $834.2 million in Q4 2024. Q1 revenue was $3.0 million, up from $1.4 million year-over-year, while net loss improved to $39.5 million from $93.8 million. R&D expenses increased to $44.8 million, and SG&A expenses rose to $27.2 million. The company's lead drug candidate obicetrapib, an oral CETP inhibitor for LDL-C reduction, saw positive developments with data presented at EAS and published in prestigious journals. Key ongoing trials include the PREVAIL Phase 3 CVOT with over 9,500 patients, VINCENT Phase 2 for Lp(a), and REMBRANDT Phase 3 for coronary plaque evaluation. Partner Menarini plans EMA submission in 2H25.