FDA Issues Nyxoah an Approvable Letter for its Genio® System
Nyxoah SA - Ordinary Shares (NYXH)
Company Research
Source: GlobeNewswire
INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced 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. The Approvable 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 codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these request
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NYXH
News
- Nyxoah Announces Issuance of First Tranche of Convertible BondsGlobeNewswire
- Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the NetherlandsGlobeNewswire
- Publication relating to transparency notificationsGlobeNewswire
- Nyxoah to Participate in the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- Nyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS RuleGlobeNewswire
NYXH
Earnings
- 11/13/25 - Miss
NYXH
Sec Filings
- 12/19/25 - Form 6-K
- 12/5/25 - Form 6-K
- 11/24/25 - Form SCHEDULE
- NYXH's page on the SEC website