Nyxoah(NYXH) Prnewswire·2025-03-31 18:10Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Nyxoah S.A. and its officers or directors, following a significant stock price drop after the FDA's Approvable Letter regarding the Genio® system [1][2][3]. Group 1: Company Developments - 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 meets regulatory requirements [2]. - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [2]. - Following the announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [2]. Group 2: Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the FDA announcement [3].