6-K - NYXH - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2025

Commission File Number: 001-40552

NYXOAH SA

(Translation of registrant’s name into English)

Rue Edouard Belin 12, 1435 Mont-Saint-Guibert,Belgium

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F x Form 40-F ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Nyxoah SA

FDA Issues Approvable Letter to Nyxoah SAfor Genio® System

On March 26, 2025, Nyxoah SA (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) issued an Approvable Letter regarding the Company’s Premarket Approval (“PMA”) application for the Genio® system.

The Approvable Letter means that the Company’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA can approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review.

This U.S. FDA decision does not impact Genio’s CE Mark or the Company’s ongoing commercial activities in Europe, where the device is marketed for both Complete Concentric Collapse (“CCC”) and non-CCC patients.

The information included under the headingFDA Issues Approvable Letter to Nyxoah SA for Genio® System shall be deemed to be incorporated by reference into the registrationstatements on Form S-8 (Registration Numbers 333-285960, 333-261233and333-269410)and Form F-3 (Registration Numbers333-285982 and 333-268955) of the Company (including any prospectuses forming a part of such registration statements) andto be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filedor furnished.

Press Release

On March 26, 2025, the Company issued a press release titled “FDA Issues Nyxoah an Approvable Letter for its Genio® System” a copy of which is attached to this Form 6-K as Exhibit 99.1.

The information in the attached Exhibit 99.1is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934,as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporatedby reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwiseset forth herein or as shall be expressly set forth by specific reference in such a filing.

Exhibits

99.1	Press Release, dated March 26, 2025

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, thereunto duly authorized.

	NYXOAH SA
Date: March 26, 2025	By:	/s/ John Landry
	Name:	John Landry
	Title:	Chief Financial Officer

Exhibit 99.1

INSIDE INFORMATION

REGULATED INFORMATION

FDA Issues Nyxoah an Approvable Letter forits Genio^®^ System

Mont-Saint-Guibert,Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system.

The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.

“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are still on the right track to make Genio available to U.S. patients suffering from OSA.”

This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.

For more information, please visit http://www.nyxoah.com/.

Caution– CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

FORWARD-LOOKING STATEMENTS

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah

John Landry, CFO

IR@nyxoah.com

For Media

In United States

FINN Partners – Alyssa Paldo

alyssa.paldo@finnpartners.com

In International/Germany

MC Services – Anne Hennecke

nyxoah@mc-services.eu

In Belgium/France

Backstage Communication – Gunther De Backer

gunther@backstagecom.be