Highlights

  • In July 2026, the CHMP adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg and its ezetimibe combination.
  • Loss for the three months ended June 30, 2026 was $64,135 thousand, compared with $17,364 thousand in the prior-year quarter.
  • Cash, cash equivalents and marketable securities were $678.3 million at June 30, 2026, with accumulated loss of $875.0 million.
  • A PREVAIL interim analysis is planned for the fourth quarter of 2026, with the recommendation expected in the first quarter of 2027.

NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) shares were trading at USD 20.49 on October 27, 2026, up 4.92%, with a relative volume at time of 2.59. The late-stage biopharmaceutical company announced in July 2026 that the CHMP of the European Medicines Agency adopted a positive opinion for obicetrapib, and it filed its quarterly report for the period ended June 30, 2026 on August 5, 2026.

NewAmsterdam Pharma was incorporated in the Netherlands in 2022 and has its principal executive offices in Naarden, The Netherlands. It is developing obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, for patients at risk of cardiovascular disease with elevated LDL-C. It has licensed commercial rights in the majority of European countries to A. Menarini International Licensing S.A. and plans to pursue U.S. development and commercialization itself, subject to marketing approval. Its fiscal year ends December 31, and its ordinary shares trade on the Nasdaq Global Market.

Second Quarter and Six-Month Results

Figures below are from the unaudited condensed consolidated statements for the periods ended June 30, 2026. Revenue was $3,701 thousand for the three months, compared with $19,145 thousand a year earlier. The company said the comparative period included $16.1 million of revenue from the second installment of development cost contributions under the Menarini License, which did not recur.

Research and development expenses were $41,673 thousand, compared with $27,516 thousand. Selling, general and administrative expenses were $26,892 thousand, compared with $27,264 thousand. Operating loss was $64,864 thousand, compared with $35,635 thousand. The fair value change on warrants was a loss of $4,555 thousand. Loss for the period was $64,135 thousand, and net loss per ordinary share, basic and diluted, was $0.52, compared with $0.15.

For the six months, revenue was $6,741 thousand, compared with $22,123 thousand. Operating loss was $123,284 thousand, compared with $104,560 thousand, and loss for the period was $112,576 thousand, compared with $56,891 thousand. Net loss per ordinary share was $0.92, compared with $0.48.

Balance Sheet and Cash Flow

The company reported cash, cash equivalents and marketable securities of $678.3 million as of June 30, 2026, and an accumulated loss of $875.0 million. It said it has incurred losses in each annual period since inception, expects to continue to incur losses for the foreseeable future, and is not yet profitable.

Net cash used in operating activities was $69,818 thousand for the six months, compared with $74,139 thousand. Net cash provided by financing activities was $22,106 thousand. Cash, cash equivalents and restricted cash were $425,508 thousand at June 30, 2026. The company did not sell shares under its at-the-market sales agreement during the six months, and 69,371 warrants were exercised for gross proceeds of $0.8 million. At August 3, 2026, 119,537,169 ordinary shares were outstanding.

Regulatory and Clinical Developments

Menarini's marketing authorization applications for obicetrapib 10 mg and the fixed-dose combination were accepted for review by the EMA in August 2025, and applications were also accepted in the United Kingdom and Switzerland. After the CHMP opinion in July 2026, the company said it anticipates Menarini will receive decisions from each regulator later this year. If approved, Menarini could potentially launch in Germany and the United Kingdom in the fourth quarter of 2026.

Outlook and Planned Milestones

The company has not issued financial guidance in the filing. It said it plans to announce additional clinical data from the BROADWAY, TANDEM and BROOKLYN Phase 3 trials during 2026. The PREVAIL cardiovascular outcomes trial enrolled at least 9,000 patients, and the company decided to conduct an interim analysis in the fourth quarter of 2026 by the independent Data Safety Monitoring Board. It expects the DSMB recommendation in the first quarter of 2027 and, if the trial continues, expects to complete PREVAIL by the end of 2027. Topline data from the RUBENS Phase 3 trial are expected by year end 2026.