Core Viewpoint - Nyxoah S.A. is under investigation for possible securities fraud following a significant stock price decline after the FDA's Approvable Letter regarding its Genio® system [1][4]. Group 1: Company Announcement - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially met regulatory requirements [3]. - Final approval from the FDA is pending a satisfactory review of Nyxoah's manufacturing facilities, methods, and controls [3]. Group 2: Market Reaction - Following the FDA announcement, analysts predicted a delay in the commercial launch of the Genio® system, leading to a stock price decline of $2.42 per share, or 21.36%, closing at $8.91 on March 26, 2025 [4]. Group 3: Legal Actions - The Portnoy Law Firm has initiated an investigation into Nyxoah for possible securities fraud and may file a class action on behalf of investors who incurred losses [1]. - Investors are encouraged to contact the law firm for a complimentary case evaluation and to discuss options for recovering their losses [2][5].
Nyxoah S.A. Investors: Company Investigated by the Portnoy Law Firm