NYXH Investors Have Opportunity to Join Nyxoah S.A. Fraud Investigation with the Schall Law Firm

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Nyxoah issues a press release on March 25, 2025, "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." Analyst noted that the Company's announcement will likely result in a delay in Genio's commercial launch. Based on this news, shares of Nyxoah fell by more than 21.3% on the next day.