NewAmsterdam Pharma Company N.V. reports news on its late-stage clinical biopharmaceutical work in oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C. The company’s principal program centers on obicetrapib, an oral, low-dose CETP inhibitor, evaluated alone and as a fixed-dose combination with ezetimibe as an adjunct to statin therapy.
Recurring updates include Phase 3 clinical data from programs such as BROADWAY, TANDEM, BROOKLYN and PREVAIL, safety and tolerability analyses, regulatory-review activity, financial results, corporate presentations and scientific-conference disclosures. NewAmsterdam also reports Nasdaq inducement grants and other equity-compensation actions tied to its public-company governance.
NewAmsterdam Pharma (NAMS) approved inducement share options covering 71,800 ordinary shares for seven non-executive new hires, granted on October 1, 2026.
The options have a $24.16 exercise price, matching the ordinary shares’ Nasdaq closing price on the grant date. They vest over four years: 25% after one year and the balance in 36 equal monthly installments. The Compensation Committee also approved 17,745 restricted stock units for seven non-executive new hires, granted on October 1, 2026. These awards vest in equal thirds over three years. Both awards require continued service on the vesting dates and were granted under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma (NAMS) dosed the first participant in its Phase 2b SPINOZA trial of obicetrapib for preclinical Alzheimer's disease.
The randomized, placebo-controlled study plans to enroll approximately 400 adults with biomarker evidence of early Alzheimer's disease pathology and no noticeable memory or functional symptoms. Participants will receive obicetrapib 10 mg or placebo for 52 weeks, with assignment stratified by ApoE genotype. The primary endpoint is change from baseline to Week 52 in blood p-tau217, a marker associated with Alzheimer's disease pathology. Secondary measures include other blood biomarkers and a cognitive score. Eligible participants may then enter an open-label extension lasting at least 26 weeks.
In a prespecified analysis of the Phase 3 BROADWAY trial, obicetrapib showed lower absolute p-tau217 changes than placebo over 12 months in the full analysis set and ApoE4 carriers.
NewAmsterdam Pharma (NAMS) and partner Menarini have received European Commission marketing authorization for Ubeslo (10 mg obicetrapib monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe), the first global regulatory approval of obicetrapib, for adults with primary hypercholesterolaemia, including heterozygous familial, and mixed dyslipidaemia.
The approval is based on Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with the fixed-dose combination versus placebo, with tolerability comparable to placebo. Under an exclusive European licensing agreement, Menarini will handle regulatory and commercial activities, while NewAmsterdam is eligible for tiered double-digit royalties on net sales in Europe and up to an additional €833 million tied to clinical, regulatory and commercial milestones. Multiple Phase 3 trials, including the PREVAIL cardiovascular outcomes study with over 9,500 patients enrolled, remain ongoing.
NewAmsterdam Pharma (NAMS) granted equity inducement awards under its 2024 Inducement Plan pursuant to Nasdaq Listing Rule 5635(c)(4) to several new employees, including its new principal accounting officer.
The Compensation Committee approved share options covering an aggregate of 52,900 ordinary shares, including 38,900 options for five non-executive new hires and 14,000 options for Robert Gunning, Vice President, Controller. The options were granted on September 1, 2026 at an exercise price of $24.92 per share, equal to the closing market price that day, and vest over four years, with 25% after one year and the remainder in 36 monthly installments, subject to continued service. The Committee also granted restricted stock units (RSUs) covering 11,900 ordinary shares, including 8,700 RSUs for the five non-executive hires and 3,200 RSUs for Mr. Gunning. These RSUs, granted on September 1, 2026, vest over three years in equal annual installments, subject to continued service and the terms of the plan and award agreements.
NewAmsterdam Pharma (NAMS) will participate in two investor conferences in September 2026: the Wells Fargo 21st Annual Healthcare Conference in Boston on September 9, and the Cantor Global Healthcare Conference 2026 in New York on September 10.
Company executives, including CEO Michael Davidson, CFO Ian Somaiya, and Head of Investor Relations Matthew Philippe, will join fireside chats at 3:45 p.m. ET and 2:45 p.m. ET, respectively. Live webcasts and archived replays of both presentations will be accessible via the investor relations section of NewAmsterdam Pharma’s website.
NewAmsterdam Pharma (Nasdaq: NAMS) will present new data from its obicetrapib development program at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, from August 28–31, 2026. Three presentations will cover Lp(a) variability, pooled lipid-lowering efficacy of CETP inhibitor obicetrapib, and the relationship between extreme HDL-C levels and mortality.
According to NewAmsterdam, prior Phase 2 and Phase 3 trials of obicetrapib showed statistically significant LDL-C reductions with a placebo-like side effect profile. The Phase 3 PREVAIL cardiovascular outcomes trial, which began in March 2022, completed enrollment in April 2024 with over 9,500 patients.
NewAmsterdam Pharma (Nasdaq: NAMS) reported that its Board Compensation Committee granted inducement equity awards under the company’s 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4). Three non-executive new hires received share options covering an aggregate of 28,000 ordinary shares with an exercise price of $27.79, equal to the July 31, 2026 Nasdaq closing price. These options vest over four years, with 25% after one year and the remainder in 36 monthly installments, subject to continued service.
The committee also granted 8,200 restricted stock units (RSUs) in aggregate to the same group, effective August 1, 2026. The RSUs vest over three years in equal annual installments, also contingent on continued employment and governed by the 2024 Inducement Plan and related award agreements.
NewAmsterdam Pharma (Nasdaq: NAMS) reported second quarter 2026 results and a corporate update, highlighted by a July 2026 positive CHMP opinion recommending EU marketing authorization for obicetrapib 10 mg monotherapy and a 10 mg obicetrapib/10 mg ezetimibe fixed-dose combination for primary hypercholesterolemia and mixed dyslipidemia. A final European Commission decision is expected later in 2026.
The company is running multiple Phase 3 programs, including the PREVAIL cardiovascular outcomes trial (over 9,500 patients enrolled; interim analysis planned 4Q2026 with results expected 1Q2027), REMBRANDT (323-patient imaging trial; enrollment completed March 2026), and RUBENS (≈300 patients; topline data targeted by year-end 2026). Additional BROADWAY analyses showed statistically significant reductions in Alzheimer’s biomarker p-tau217 versus placebo.
As of June 30, 2026, NewAmsterdam reported $678.3 million in cash, cash equivalents and marketable securities, versus $728.9 million at December 31, 2025. Q2 2026 revenue was $3.7 million (down from $19.1 million a year earlier), R&D expenses were $41.7 million, SG&A expenses were $26.9 million, and net loss widened to $64.1 million from $17.4 million.
NewAmsterdam Pharma (Nasdaq: NAMS) will host an Investor Day on August 5, 2026, beginning at 9:00 a.m. ET in New York City, featuring presentations from its CEO, founder/CSO, CCO, CFO and Head of Investor Relations.
A live webcast with supporting presentation materials will be accessible via the Events section of NewAmsterdam’s investor relations website, with an archived replay available afterwards. In-person attendance requires advance registration. The company will discuss obicetrapib, its late-stage, oral CETP inhibitor, including ongoing Phase 3 programs such as the PREVAIL cardiovascular outcomes trial.
NewAmsterdam Pharma (Nasdaq: NAMS) and its partner Menarini Group received a positive CHMP opinion recommending EU marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe FDC) to treat primary hypercholesterolemia, including HeFH, and mixed dyslipidemia.
The recommendation is based on Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed statistically significant LDL-C reductions up to about 40% with obicetrapib monotherapy and about 50% in combination with ezetimibe versus placebo, with tolerability comparable to placebo. The opinion now goes to the European Commission, with a decision expected in 2H26 and potential centralized authorization across the EU and EEA if granted.
Under a licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory and commercial activities, while NewAmsterdam is eligible for tiered double‑digit royalties on net sales in the Menarini territory and up to an additional €833 million in clinical, regulatory and commercial milestones.