European Medicines Agency Endorses NewAmsterdam Pharma’s Obicetrapib Therapies Ubeslo® and Evlarco® for Marketing Approval

EMA’s Positive Recommendation for Obicetrapib-Based Cardiovascular Therapies

NewAmsterdam Pharma Company N.V., headquartered in the Netherlands, disclosed on July 24, 2026, that the European Medicines Agency’s CHMP has issued a favorable opinion endorsing marketing authorization for its two obicetrapib formulations: Ubeslo® and Evlarco®. This positive CHMP recommendation is a pivotal regulatory step in the European approval process for these cardiovascular treatments. The announcement highlights the collaborative regulatory effort with the Menarini Group, emphasizing a strategic partnership to bring these therapies to European patients.

The CHMP’s positive opinion is a critical prerequisite before formal marketing authorization by the European Commission. Comprising experts from EU member states, the committee rigorously assesses the safety, efficacy, and benefit-risk profile of new medicinal products. Both the monotherapy and fixed-dose combination formulations have successfully passed this evaluation, indicating regulatory confidence in the clinical and manufacturing data submitted.

Detailed Profiles of Ubeslo® and Evlarco®

The regulatory submission covers two obicetrapib-based treatment options progressing through Europe’s approval pathway. Ubeslo® is the monotherapy formulation providing obicetrapib as a standalone treatment, while Evlarco® combines obicetrapib with ezetimibe in a fixed-dose combination, offering a dual-action therapeutic approach. Although the announcement does not explicitly state the indication, the inclusion of ezetimibe suggests these products target cardiovascular conditions or lipid metabolism disorders, as ezetimibe is widely used for cholesterol management.

Offering both monotherapy and combination therapy options enables tailored treatment strategies based on patient needs and clinical contexts. The simultaneous positive opinion for both formulations reflects the committee’s endorsement of their suitability for patient use. Specific details regarding dosing regimens, targeted patient populations, or clinical efficacy data were not disclosed in the announcement.

Strategic Partnership with Menarini Group in European Regulatory Process

The collaboration between NewAmsterdam Pharma and the Menarini Group has been instrumental in achieving this regulatory milestone. Both companies are named recipients of the positive CHMP opinion, indicating a joint regulatory submission and shared responsibilities for the development and commercialization of these therapies in Europe. Menarini Group’s established European presence and distribution network enhance the partnership’s strategic value for market access.

This alliance likely strengthens the pathway toward formal marketing authorization and commercial launch. While the filing does not detail the specific terms, financial arrangements, or division of responsibilities, such partnerships typically encompass regulatory submissions, manufacturing, distribution, and market introduction activities.

Regulatory Outlook and Next Steps for European Approval

The CHMP’s positive opinion represents an intermediate but vital step toward final European marketing authorization. Following this recommendation, the European Commission usually issues the formal decision on authorization. The filing does not specify timelines for this final approval or when European patients might access these therapies if authorized. Investors are expected to monitor forthcoming updates regarding the European Commission’s decision schedule.

Europe’s regulatory process involves multiple stages to ensure drug safety and efficacy prior to market entry. It remains unclear whether this positive opinion relates to a standard or accelerated review pathway, or if any post-approval monitoring or conditions apply. Future disclosures will likely clarify the regulatory status and anticipated timeline for formal authorization.

Commercial Potential and Market Access Implications

The favorable European regulatory opinion supports potential market access across EU member states and other countries recognizing EMA decisions. This progress represents a significant commercial opportunity for NewAmsterdam Pharma, especially if these therapies address unmet cardiovascular treatment needs or offer advantages over existing options. The availability of both monotherapy and combination formulations offers flexibility for healthcare providers and patients.

The announcement does not include market size estimates, pricing strategies, or launch timelines for Europe or other regions. It also does not mention regulatory approvals or submissions in other jurisdictions such as the United States. Investors interested in the global commercial outlook for Ubeslo® and Evlarco® may await further updates on regulatory developments outside Europe.

Clinical Evidence and Regulatory Confidence Underpinning Positive Opinion

The positive CHMP opinion indicates that NewAmsterdam Pharma and Menarini Group provided comprehensive clinical data demonstrating the safety and efficacy of both obicetrapib formulations in accordance with European standards. The committee’s favorable assessment reflects confidence in the risk-benefit profile of these therapies. However, the filing does not disclose specific clinical trial details, patient demographics, or efficacy endpoints supporting the recommendation.

This endorsement typically also signifies confidence in manufacturing quality and product consistency. The company has not revealed the size or geographic scope of clinical programs or any safety concerns identified during review. Such information is generally detailed in the European Public Assessment Report following final marketing authorization.

NewAmsterdam Pharma’s Regulatory Strategy and Corporate Positioning

Progressing obicetrapib-based therapies through European regulatory channels highlights NewAmsterdam Pharma’s commitment to delivering innovative cardiovascular treatments to key pharmaceutical markets. The July 2026 announcement aligns with the company’s broader development strategy for this program. No information was provided about other pipeline candidates or future regulatory filings planned for 2026 or beyond.

NewAmsterdam Pharma operates with expertise in European regulatory affairs and maintains strategic partnerships with established pharmaceutical entities to support market access. Headquartered in Naarden, Netherlands, the company is well-positioned within the European regulatory and commercial environment. The immediate impact on share price following the announcement was not disclosed.

Trading Information for NewAmsterdam Pharma Securities

NewAmsterdam Pharma’s ordinary shares are listed on NASDAQ under the ticker NAMS, while warrants to purchase ordinary shares trade under the ticker NAMSW. Both securities are registered on the Nasdaq Stock Market LLC. The company’s ordinary shares have a nominal value of €0.12 each. The filing does not provide current trading volumes, share prices, or warrant exercise data as of the July 24, 2026 announcement.

Investors holding shares or warrants may view the positive CHMP opinion as a significant development enhancing the company’s pipeline value and potential revenue prospects. This regulatory progress confirms advancement of at least one therapeutic program through a critical European market checkpoint. The filing does not clarify if the opinion triggers contractual milestones or payments under the Menarini partnership.

Additional Filings and Disclosure Details

The company filed a press release dated July 24, 2026, as Exhibit 99.1 accompanying the current report. This release contains the original announcement of the positive CHMP opinion and is incorporated by reference. The filing also includes an Inline XBRL cover page interactive data file as Exhibit 104, complying with SEC data standardization requirements.

The filing was signed by Mike Marino, Chief Legal Officer of NewAmsterdam Pharma Company N.V., on July 24, 2026, certifying the accuracy and completeness of the disclosure under applicable securities laws. Investors seeking further details on the obicetrapib programs, clinical results, or partnership terms with Menarini Group should consult the company’s press release and future regulatory filings.