NewAmsterdam Pharma Co N.V.

NewAmsterdam Pharma announced a positive CHMP opinion recommending marketing authorization for obicetrapib and its fixed-dose combination in Europe, a significant regulatory milestone. The company also provided updates on its clinical pipeline, including planned interim analysis for PREVAIL in Q4 2026 and topline data for RUBENS by year-end 2026. Financially, the company reported $678.3 million in cash, cash equivalents, and marketable securities as of June 30, 2026. Revenue for the second quarter was $3.7 million, with a net loss of $64.1 million, reflecting increased R&D investments.

NewAmsterdam Pharma reported a significant widening of its net loss for the second quarter of 2026, reaching $64.1 million, compared to $17.4 million in the same period last year. Revenue for the quarter also saw a substantial decline of 80.6% to $3.7 million. The company experienced increased research and development expenses and a decrease in cash and cash equivalents. Additionally, the company adopted an Employee Stock Purchase Plan and changed the valuation method for its Public Warrant liabilities.

NewAmsterdam Pharma Co N.V. announced it will host an Investor Day event for analysts and investors on August 5, 2026, starting at 9:00 a.m. ET in New York City. Key members of the management team, including CEO Michael Davidson and CFO Ian Somaiya, will attend. A live webcast will be available for virtual participants, with pre-registration required, and presentation materials will be posted on the company's investor relations website.

NewAmsterdam Pharma Co N.V. and its partner Menarini Group have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This recommendation is for marketing authorization of Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination) for patients with primary hypercholesterolemia in Europe. The positive opinion is supported by data from Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed significant LDL-C reductions. A final decision from the European Commission is anticipated in the second half of 2026.

NewAmsterdam Pharma Company N.V. announced that the European Medicines Agency's CHMP adopted a positive opinion recommending marketing authorization for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib/ezetimibe fixed-dose combination). This recommendation is for patients with primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. The positive opinion is based on data from Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which demonstrated significant LDL-C reductions. A final decision from the European Commission is anticipated in the second half of 2026, with partner Menarini Group holding exclusive commercialization rights in Europe.

NewAmsterdam Pharma Company N.V. announced that Douglas Kling will resign from his position as Chief Operating Officer, effective August 14, 2026. Mr. Kling is leaving to take on a chief executive officer role at another clinical-stage biotech company. The company plans to enter into a separation agreement and an advisor agreement with Mr. Kling to ensure a smooth transition, with advisory services focused on the PREVAIL clinical trial of obicetrapib and other clinical programs.

NewAmsterdam Pharma announced that its Compensation Committee approved the grant of inducement equity awards to four new non-executive hires. The grants include 28,700 share options with an exercise price of $35.17, vesting over four years. Additionally, 8,100 restricted stock units were granted, vesting over three years. These awards were made under the 2024 Inducement Plan to attract new talent.

NewAmsterdam Pharma announced it will present data on obicetrapib's potential for early Alzheimer's disease prevention at the Alzheimer's Association International Conference (AAIC) 2026. Analysis from the BROADWAY trial showed statistically significant lower absolute changes in p-tau217, a key Alzheimer's biomarker, compared to placebo over 12 months in both the full analysis set and in ApoE4 carriers. The drug was also well-tolerated in the trial, with safety results comparable to placebo, highlighting its multi-pathway effects beyond LDL-C lowering.

NewAmsterdam Pharma Co N.V. held its 2026 Annual General Meeting, where shareholders approved the 2026 Employee Stock Purchase Plan (ESPP). The ESPP allows eligible employees to purchase up to 1,150,000 ordinary shares at a 15% discount. Additionally, shareholders approved the 2025 annual accounts, discharged directors from liability, appointed Deloitte Accountants B.V. as auditor, re-appointed two non-executive directors, and extended the Board's authorization to issue ordinary shares until June 2, 2031.

NewAmsterdam Pharma announced it will present data on obicetrapib, its oral, non-statin medicine for cardiovascular disease, at the National Lipid Association (NLA) 2026 Scientific Sessions from June 11-14, 2026. The presentations will highlight obicetrapib's potential as a novel therapy for hypercholesterolemia, covering safety, efficacy, and impact on kidney function from various clinical trials. The company is developing obicetrapib to address limitations of current LDL-lowering treatments.