Nyxoah (NYXH) FDA Approvals $1.62 0.00 (0.00%) Closing price 09/4/2026 04:00 PM EasternExtended Trading$1.67 +0.05 (+3.09%) As of 05:57 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsNews and TrendsOwnershipSEC Filings Nyxoah's Drug in the FDA Approval ProcessThis 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. Provided Update - September 7,2026Provided Update Drug: GenioAnnounced Date: September 7, 2026Indication: For the Treatment of Obstructive Sleep ApneaAnnouncementNyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates.Read AnnouncementFDA approved - August 8,2025Fda Approved Drug: GenioAnnounced Date: August 8, 2025Indication: For the Treatment of Obstructive Sleep ApneaAnnouncementNyxoah 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.AI SummaryNyxoah 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.Read Announcement 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 September 7, 2026, involving Genio. The update was categorized as "Provided Update," with the company reporting: "Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates." 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. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Upstream Bio FDA EventsAscendis Pharma A/S FDA EventsNyxoah FDA EventsRoivant Sciences FDA EventsGuardant Health FDA EventsInhibrx Biosciences FDA EventsIonis Pharmaceuticals FDA EventsRein Therapeutics FDA EventsBiogen FDA EventsC4 Therapeutics FDA EventsClimb Bio FDA EventsDyne Therapeutics FDA EventsHarmony Biosciences FDA EventsInsmed FDA EventsLiquidia FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies KORU Medical Systems FDA Events Apyx Medical FDA Events Microbot Medical FDA Events RenovoRx FDA Events electroCore FDA Events Nano-X Imaging FDA Events Envoy Medical FDA Events PAVmed FDA Events Inspira Technologies OXY B.H.N. FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:NYXH last updated on 9/8/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersA Simple Guide to Options Trading While It's Still FreeA free copy of Options Trading Made Simple is available now but wont stay that way for long. Chris Rowe cal...True Market Insiders | SponsoredThe trade I’ve been waiting for since 2011Ross Givens, Director of Research at Traders Agency, is calling for gold to reach $10,000 an ounce this superc...Traders Agency | SponsoredWhy the Treasury still prices gold at 42 dollars an ounceThe U.S. Treasury still values its gold reserves at 42.22 dollars an ounce, a price set in 1973. Gold trades n...Golden Portfolio | SponsoredThey're not buying gold. They're buying this.Bank of America raised its stake in a small gold company by 139%. 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Provided Update - September 7,2026Provided Update Drug: GenioAnnounced Date: September 7, 2026Indication: For the Treatment of Obstructive Sleep ApneaAnnouncementNyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates.Read Announcement
FDA approved - August 8,2025Fda Approved Drug: GenioAnnounced Date: August 8, 2025Indication: For the Treatment of Obstructive Sleep ApneaAnnouncementNyxoah 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.AI SummaryNyxoah 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.Read Announcement
