Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 17

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 17
---
 staff, if any, may be. The next FDA user fee reauthorization
package is expected to enter stakeholder negotiations beginning in mid-2025, with any agreement sent to Congress in early 2027 for purposes
of initiating the legislative process. Reauthorization of the medical device user fee program would need to be finalized by Congress by
the end of September 2027 in order to avoid a disruption in FDA’s review goals for device marketing authorizations and other activities
supported by user fees assessed against industry.

The information included under the headings “FDA Approval,” “Preliminary, Unaudited Second Quarter 2025 Financial Results and Business Updates” and “Risk Factors” shall be deemed to be incorporated by reference into the registration statements on Forms S-8 (Registration Numbers 333-285960, 333-261233and 333-269410) and Forms F-3 (Registration Numbers 333-268955and 333-285982) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

The information in the attached Exhibits 99.1 and 99.2 are 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 incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

Exhibits

<div align='center'>SIGNATURES</div>

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.

| Date: August 11, 2025 | NYXOAH SA 
 By:       | /s/ John Landry         |
|:----------------------|:----------|:------------------------|
|                       | Name:     | John Landry             |
|                       | Title:    | Chief Financial Officer |