Nyxoah Provides Update on FDA Approvable Letter for Genio System
Nyxoah SA - Ordinary Shares (NYXH)
Company Research
Source: GlobeNewswire
Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) 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 satisfac
Show less
Read more
Impact Snapshot
Event Time:
NYXH
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
NYXH alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
NYXH alerts
High impacting Nyxoah SA - Ordinary Shares news events
Weekly update
A roundup of the hottest topics
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