Nyxoah S.A.

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Investigation Details

Nyxoah issued a press release on March 25, 2025, “announc[ing] 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”, which “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.” Following Nyxoah’s announcement, analysts projected that Genio’s commercial launch would be delayed pending further review by the FDA.

Following this news, Nyxoah’s stock price fell over 21% on March 26, 2025.