Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Nyxoah S.A. (“Nyxoah” or “the Company”) (NASDAQ: NYXH). Investors who purchased Nyxoah securities are encouraged to obtain additional information and assist the investigation.

The investigation concerns whether Nyxoah has violated federal securities laws.

Investigation Details

On March 25, 2025, Nyxoah issued a press release “announcing 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”, adding that the 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 … and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review.” Analysts noted that the Company’s announcement will likely result in a delay in Genio’s commercial launch. Following this news, Nyxoah stock dropped more than 21.3% the next day.

What’s Next?

If you are aware of any facts relating to this investigation or purchased Nyxoah securities, you can assist this investigation. You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660