| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 1, 2025 4:00 P.M. |
| Form: | F-3 | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 1, 2025 4:00 P.M. |
| Form: | F-3 | ||||||
| |||||||
Save time and jump to the most important pieces.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/31/2023 | Buy | H.C. Wainwright | |
| 7/19/2023 | Neutral | Robert W. Baird | |
| 4/21/2022 | $30.00 | Outperform | Oppenheimer |
| 4/6/2022 | $21.00 | Peer Perform | Wolfe Research |
| 12/21/2021 | $47.00 | Overweight | Cantor Fitzgerald |
| 7/28/2021 | $43.00 | Overweight | Cantor Fitzgerald |
| 7/28/2021 | $40.00 | Overweight | Piper Sandler |
| 7/27/2021 | $43.00 | Buy | Stifel |
INSIDE INFORMATIONREGULATED INFORMATION Conditional Issuance of Shares Mont-Saint-Guibert, Belgium – April 16, 2025, 8:00 am CET / 2:00 am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), today announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs (the "ATM"). This brings the aggregate number of ordinary shares that can be sold and issued under the Company's ATM to 5,662,694 (the "ATM Shares"), which includes 662,694 shares that are still available from the conditional issuance of shares under the ATM decided upon on December 22, 2022. Pursuant to the existing sales agreement entered into
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 L
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, D
SC 13D/A - Nyxoah SA (0001857190) (Subject)
SC 13D/A - Nyxoah SA (0001857190) (Subject)
SC 13G/A - Nyxoah SA (0001857190) (Subject)
6-K - Nyxoah SA (0001857190) (Filer)
6-K - Nyxoah SA (0001857190) (Filer)
EFFECT - Nyxoah SA (0001857190) (Filer)
REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating ResultsFDA PMA Application Review Nearing ConclusionPositioned for U.S. Commercial Launch in March 2025 Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the fourth quarter and financial year 2024. Recent Financial and Operating Highlights Revenue for the fourth quarter of 2024 was €1.3 million, which excludes €0.6 million of deferred rev
Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Mont-Saint-Guibert, Belgium – Monday, March 10, 2025, 10:05pm CET / 5:05pm 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 Company will release financial results for the fourth quarter and financial year 2024 on Thursday, March 13, 2025. Company management will host a conference call to discuss financial results that day beginning 1:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxo
REGULATED INFORMATION Nyxoah Reports Third Quarter Financial and Operating ResultsFDA approval on track for first quarter 2025, U.S. commercial team build out in progressCompany fully funded with cash until mid 2026 Mont-Saint-Guibert, Belgium – November 6, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024. Recent Financial and Operating Highlights Presented compelling DREAM data results at International
Nyxoah Appoints John Landry as Chief Financial Officer Current CFO, Loïc Moreau, to Transition into Role of President International Mont-Saint-Guibert, Belgium – November 4, 2024, 10:45pm CET / 4:45pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the appointment of John Landry as Chief Financial Officer (CFO), effective November 4, 2024. This strategic appointment, in combination with the recent move to the United States of CEO Olivier Taelman, strengthens the Company's focus on the U.S. market. Mr. Landry
Nyxoah Appoints Scott Holstine as Chief Commercial Officer Mont-Saint-Guibert, Belgium – July 15, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (NASDAQ:NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Scott Holstine as Chief Commercial Officer. In this role, Scott will lead the commercial operations of Nyxoah enabling a successful U.S. launch. Scott brings over 26 years of experience in the medical device industry with a proven track record in U.S. product launches, building and leading commercial organizations trademarked by
Nyxoah Strengthens its Executive Leadership TeamFrancis Kim appointed as Chief Regulatory and Quality Officer Mont-Saint-Guibert, Belgium – November 28, 2023, 10:30pm CET / 4:30pm ET – Nyxoah SA (NASDAQ:NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Francis Kim as Chief Regulatory and Quality Officer. Francis will be leading Nyxoah's Global Regulatory and Quality departments. Francis is a highly experienced global regulatory and quality executive in the healthcare industry, having spent more than 25 years in the medical device
H.C. Wainwright initiated coverage of Nyxoah S.A. with a rating of Buy
Robert W. Baird initiated coverage of Nyxoah S.A. with a rating of Neutral
Oppenheimer initiated coverage of Nyxoah S.A. with a rating of Outperform and set a new price target of $30.00