Nyxoah (NYXH) FDA Approvals

Nyxoah's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Nyxoah (NYXH). Over the past two years, Nyxoah has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Genio. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Genio FDA Regulatory Events

Genio is a drug developed by Nyxoah for the following indication: For the Treatment of Obstructive Sleep Apnea. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA approved - August 8,2025

• Drug: Genio
• Announced Date: August 8, 2025
• Indication: For the Treatment of Obstructive Sleep Apnea

Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Nyxoah SA announced that the U.S. Food and Drug Administration has approved the Genio system for treating obstructive sleep apnea in patients with an Apnea-Hypopnea Index (AHI) between 15 and 65. Genio uses bilateral hypoglossal nerve stimulation with a leadless implant, a non-implanted battery solution, and a full-body 1.5T/3T MRI-compatible wearable controller.

The wearable component powers, controls, and can be fully upgraded for software and battery without surgery. In the DREAM pivotal trial, Genio met key safety and efficacy endpoints. It achieved a 63.5% AHI responder rate, a 71.3% oxygen desaturation responder rate, and a 70.8% median AHI reduction.

Moreover, 82% of participants lowered their AHI to below 15. Genio proved effective in all sleeping positions, cutting AHI by 66.6% when patients lay on their back and by 71% in other positions.

Olivier Taelman, Nyxoah’s CEO, said this approval marks a milestone in bringing innovative, simple sleep therapy to U.S. patients with moderate to severe OSA.

Nyxoah FDA Events - Frequently Asked Questions

Has Nyxoah received FDA approval?

As of now, Nyxoah (NYXH) has not received any FDA approvals for its therapy in the last two years.

What drugs has Nyxoah submitted to the FDA?

In the past two years, Nyxoah (NYXH) has reported FDA regulatory activity for Genio.

What is the most recent FDA event for Nyxoah?

The most recent FDA-related event for Nyxoah occurred on August 8, 2025, involving Genio. The update was categorized as "FDA approved," with the company reporting: "Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65."

What conditions do Nyxoah's current drugs treat?

Currently, Nyxoah has one therapy (Genio) targeting the following condition: For the Treatment of Obstructive Sleep Apnea.