NewAmsterdam Plans to Release Obicetrapib Trial Data in 2026
Following the completion and topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe during 2026. The following Phase 3 trials are currently ongoing: PREVAIL Phase 3 trial: PREVAIL is a CVOT evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024. REMBRANDT Phase 3 trial: The REMBRANDT trial utilizes coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque burden. The placebo-controlled, double-blind, randomized, Phase 3 trial is being conducted in adult participants with high-risk ASCVD with evidence of coronary plaque who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The trial is expected to complete enrollment of approximately 300 patients in 2026. RUBENS Phase 3 trial: Initiated in December 2025, the RUBENS trial will evaluate obicetrapib alone or in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy. The trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026. Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer's disease patients in 2026.
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Inducement Grants: Amsterdam Pharma reports on the availability of inducement grants aimed at supporting companies listed under NASDAQ.
NASDAQ Listing Rule 5635(c)(4): The article discusses the specific NASDAQ listing rule that governs the issuance of inducement grants to attract and retain talent.
- Annual Revenue Performance: NewAmsterdam Pharma reported FY 2025 revenue of $22.5 million, indicating growth; however, the overall financial situation remains challenging, reflecting competitive pressures in the market.
- Net Loss Improvement: The net loss for 2025 was $203.8 million, an improvement from $241.6 million in 2024, suggesting progress in cost control and operational efficiency.
- Cash Flow Status: As of December 31, 2025, NewAmsterdam's cash, cash equivalents, and marketable securities totaled $728.9 million, down from $834.2 million in 2024, indicating pressure on the company's financial management.
- Market Outlook Analysis: Despite improvements in financial data, ongoing net losses and declining cash flow may affect investor confidence, necessitating effective strategies from NewAmsterdam to enhance market competitiveness and financial health.
- Regulatory Approval Progress: NewAmsterdam Pharma's Marketing Authorization Applications for obicetrapib and its fixed-dose combination with ezetimibe have been accepted by EMA, UK, and Swiss regulators, with approval decisions expected in the second half of 2026, laying the groundwork for market entry in the cardiovascular disease sector.
- Clinical Trial Data: Topline data from the RUBENS Phase 3 trial is anticipated by the end of 2026, evaluating the efficacy of obicetrapib in patients with type 2 diabetes and metabolic syndrome requiring further LDL-C reduction, which could enhance the company's competitive position in the cardiovascular drug market.
- Strong Financial Position: As of December 31, 2025, NewAmsterdam reported $728.9 million in cash, cash equivalents, and marketable securities, a decrease from 2024, yet sufficient to fund operations through the PREVAIL trial readout and potential U.S. market launch.
- R&D Expense Changes: R&D expenses for 2025 were $141.8 million, down from $151.4 million in 2024, primarily due to the completion of several Phase 3 clinical trials, indicating effective cost control and resource optimization by the company.
- Put Option Appeal: The $30.00 put option for NAMS has a current bid of 20 cents, and if an investor sells this contract, they commit to buying shares at $30.00, effectively lowering their cost basis to $29.80, which is about a 6% discount from the current price of $31.77, making it attractive for those looking to enter at a lower price.
- Yield Potential: Should the put option expire worthless, it would yield a 0.67% return on cash commitment, or an annualized yield of 3.86%, referred to as YieldBoost, highlighting the potential profitability of this contract.
- Call Option Returns: The $35.00 call option has a current bid of 40 cents, and if an investor buys shares at $31.77 and sells this call, they could achieve a total return of 11.43% if the stock is called away at expiration, showcasing the potential upside of this strategy.
- Risk Assessment: Current analytics suggest a 65% chance that the $30 put option will expire worthless, while the $35 call option has a 56% chance of doing the same, indicating that investors should carefully weigh the risks and rewards when selecting their options strategies.
- Clinical Trial Progress: NewAmsterdam Pharma has enrolled its first patient in the RUBENS Phase 3 trial initiated in December 2025, which is expected to provide new treatment options for patients with metabolic syndrome, thereby enhancing the company's competitive position in the cardiovascular disease market.
- Strong Financial Position: As of December 31, 2025, NewAmsterdam reported a cash, cash equivalents, and marketable securities balance of approximately $729 million, which is sufficient to fund operations through the anticipated readout of the PREVAIL trial, ensuring future commercialization potential.
- Regulatory Advancements: The company is advancing its EMA applications for obicetrapib and its fixed-dose combination with Menarini, with an expected approval decision in 2H26, which will lay the groundwork for commercialization in the European market.
- Clear Strategic Goals: NewAmsterdam plans to initiate a clinical trial for Alzheimer's disease in 2026, further expanding the indications for obicetrapib, demonstrating the company's strategic positioning in both cardiovascular and neurodegenerative disease sectors.
- Employee Incentive Plan: NewAmsterdam Pharma's Board Compensation Committee approved the grant of 40,000 inducement share options to two non-executive new hires, aimed at attracting talent and strengthening the team in line with the 2024 Inducement Plan.
- Option Details: The options have an exercise price of $39.61 per share, based on the closing price on December 1, 2025, and will vest over four years, designed to incentivize long-term employee commitment to the company.
- Market Reaction: This move not only enhances employee loyalty and motivation but may also attract more top talent in the future, thereby strengthening the company's competitiveness and innovation capabilities.
- Strategic Significance: By implementing the inducement option plan, NewAmsterdam demonstrates its commitment to talent, aiming to fill the market gap in cardiovascular disease treatment and drive long-term growth in the biopharmaceutical industry.










