EMA accepts obicetrapib filing for NewAmsterdam (NASDAQ: NAMSW)

Rhea-AI Filing Summary

NewAmsterdam Pharma Company N.V. reports that the European Medicines Agency has validated its Marketing Authorization Application for obicetrapib 10 mg as monotherapy and for a 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination. These treatments are aimed at patients with primary hypercholesterolemia, including both heterozygous familial and non-familial cases, as well as mixed dyslipidemia.

The validation allows the EMA to begin substantive review of data from the Company’s BROADWAY, BROOKLYN and other Phase 3 clinical trials. The MAA was submitted by A. Menarini International Licensing S.A., which holds an exclusive license with a NewAmsterdam subsidiary and is responsible for European regulatory interactions, commercialization, local development of obicetrapib, and related collaborative activities.

Insights

Biopharma regulatory specialist

EMA validation moves obicetrapib into full EU regulatory review.

NewAmsterdam Pharma discloses that the European Medicines Agency has validated the Marketing Authorization Application for obicetrapib 10 mg, both as monotherapy and combined with ezetimibe for primary hypercholesterolemia and mixed dyslipidemia. Validation means the application is considered complete and can proceed to detailed assessment, which is a key regulatory step but not an approval.

The filing notes that this validation allows substantive review of results from the BROADWAY, BROOKLYN and other Phase 3 trials. This ties the regulatory process directly to late-stage clinical data, so the strength and consistency of those results will heavily influence any eventual authorization outcome.

The application was submitted by partner A. Menarini International Licensing S.A., which is responsible for EU regulatory communications, commercialization and local development under an exclusive license with a NewAmsterdam subsidiary. This structure concentrates European execution in the partner’s hands, so future disclosures on EMA review progress and commercialization plans would likely come through that collaboration framework.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 18, 2025

NewAmsterdam Pharma Company N.V.

(Exact name of Registrant as Specified in Its Charter)

The Netherlands			001-41562	N/A
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
Goomieer 2-35
Naarden
The Netherlands				1411 DC
(Address of Principal Executive Offices)				(Zip Code)
			+31 (0) 35 206 2971
(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, nominal value €0.12 per share		NAMS		The Nasdaq Stock Market LLC
Warrants to purchase ordinary shares		NAMSW		The Nasdaq Stock Market LLC

☐	Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
☐	If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 7.01 Regulation FD Disclosure.

On August 18, 2025, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing that the European Medicines Agency (the “EMA”) has validated the Marketing Authorization Application (the “MAA”) for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 7.01, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.

Item 8.01 Other Events.

On August 18, 2025, the Company announced that the EMA has validated the MAA referred to above. The validation allows for substantive review by the EMA of the Company’s BROADWAY, BROOKLYN and TANDEM Phase 3 clinical trials.

The MAA was submitted by the Company’s partner, A. Menarini International Licensing S.A., who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive license agreement with NewAmsterdam Pharma B.V., a subsidiary of the Company.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated August 18, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			NewAmsterdam Pharma Company N.V.
Date:	August 18, 2025	By:	/s/ Michael Davidson
		Name:	Michael Davidson, M.D.
		Title:	Chief Executive Officer

FAQ

What regulatory milestone did NewAmsterdam Pharma (NAMSW) announce?

NewAmsterdam Pharma announced that the European Medicines Agency has validated the Marketing Authorization Application for obicetrapib 10 mg monotherapy and a 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination.

For which conditions is obicetrapib being reviewed by the EMA?

The EMA validation covers obicetrapib for patients with primary hypercholesterolemia, including both heterozygous familial and non-familial cases, as well as mixed dyslipidemia.

What does EMA validation of the Marketing Authorization Application mean for NewAmsterdam Pharma?

Validation means the EMA has accepted the Marketing Authorization Application as complete, allowing substantive review of the Company’s BROADWAY, BROOKLYN and Phase 3 clinical trial data to begin.

Which partner submitted the obicetrapib Marketing Authorization Application to the EMA?

The Marketing Authorization Application was submitted by A. Menarini International Licensing S.A., which is responsible for regulatory communications in Europe and for commercialization, local development and other collaborative activities for obicetrapib.

What role does A. Menarini International Licensing S.A. play in NewAmsterdam Pharma’s obicetrapib program?

A. Menarini International Licensing S.A. holds an exclusive license agreement with NewAmsterdam Pharma B.V., a subsidiary of the Company, and is responsible for European regulatory interactions, commercialization, local development of obicetrapib and related collaborative activities.

Which clinical trials are referenced in connection with the EMA’s review of obicetrapib?

The EMA’s substantive review will include data from NewAmsterdam Pharma’s BROADWAY, BROOKLYN and other Phase 3 clinical trials of obicetrapib.