Welcome to our dedicated page for NYXOAH S A news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on NYXOAH S A stock.
Nyxoah SA (NYSE: NYXH) is a pioneering health technology company focused on innovative treatments for sleep disordered breathing, particularly Obstructive Sleep Apnea (OSA). This page serves as the definitive source for official updates about their FDA-cleared Genio neurostimulation system, financial developments, and clinical research progress.
Investors and medical professionals will find curated press releases covering regulatory milestones, partnership announcements, and quarterly earnings reports. All content is sourced directly from company filings and verified channels to ensure accuracy.
Key focus areas include updates about international market expansions, clinical trial outcomes for OSA therapies, and technological enhancements to the Genio platform. Bookmark this page to stay informed about Nyxoah's progress in developing patient-centric solutions for chronic sleep conditions.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) has received a transparency notification from FMR LLC regarding changes in shareholding. FMR LLC and its controlled undertakings now hold 1,111,240 voting rights (2.97% of total voting rights) as of April 29, 2025, consisting of 987,776 voting rights linked to securities and 123,464 equivalent financial instruments. This represents a downward crossing below the 3% threshold.
The voting rights are distributed among Fidelity Management & Research Company LLC (2.07%), FIAM LLC (0.00%), and FMR Investment Management UK Limited (0.57%). The notification includes a stock loan as an equivalent financial instrument representing 0.33% of voting rights.
Nyxoah (Nasdaq/Euronext: NYXH), a company focused on developing innovative neuromodulation treatments for Obstructive Sleep Apnea (OSA), has scheduled its Q1 2025 financial results release for May 14, 2025. The company will host a conference call with management on the same day at 2:00pm CET / 8:00am ET.
Investors and analysts can access the earnings call through the company's Investor Relations webpage or via webcast link. Those planning to ask questions during the call should register at least 10 minutes before the start time using a separate registration link. A replay of the webcast will be available shortly after the call concludes.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) has announced a conditional issuance of up to 5 million ordinary shares through its existing at-the-market (ATM) equity offering programs. This brings the total potential ATM shares to 5,662,694, including 662,694 shares still available from a previous conditional issuance decided on December 22, 2022.
The ATM shares will be sold at prevailing USD market prices on the Nasdaq Global Market at the time of sale, in accordance with the existing sales agreement from December 22, 2022.
Nyxoah (NYXH) announced an update regarding the FDA approval process for its Genio system, a neuromodulation treatment for Obstructive Sleep Apnea (OSA). The FDA issued an Approvable Letter on March 26, 2025, indicating that the PMA application substantially meets federal requirements.
The FDA has accepted all clinical data demonstrating Genio's safety and effectiveness. Only one item remains before final approval: the validation of a process used with a component at the U.S. manufacturing site. The company expects to complete this validation and potentially receive full PMA approval in the second quarter of 2025.
Nyxoah (NYXH) has received an Approvable Letter from the FDA for its Genio® system, a neuromodulation device treating Obstructive Sleep Apnea (OSA). The letter indicates that Nyxoah's Pre-Market Approval (PMA) application substantially meets federal requirements, with final approval pending completion of manufacturing facilities, methods and controls review.
The FDA's review found no additional questions regarding clinical data or biocompatibility supporting the submission. The Genio system maintains its CE Mark and continues commercial operations in Europe, where it's approved for both Complete Concentric Collapse (CCC) and non-CCC patients.
Nyxoah (NYXH) reported its Q4 and FY 2024 financial results, highlighting key developments in its Obstructive Sleep Apnea (OSA) treatment business. Q4 2024 revenue was €1.3 million (excluding €0.6 million deferred revenue), with a strong gross margin of 73%. Full-year 2024 revenue reached €4.5 million.
The company's cash position strengthened to €85.6 million as of December 31, 2024, up from €57.7 million year-over-year. Operating losses increased to €58.8 million for FY 2024, compared to €45.1 million in 2023, reflecting increased R&D and commercial activities.
Nyxoah completed its PMA submission to the FDA for its Genio system and expects approval by Q1 end. The company has assembled its U.S. commercial team and plans to launch in March 2025.
Nyxoah (Euronext Brussels/Nasdaq: NYXH), a company developing breakthrough neuromodulation treatments for Obstructive Sleep Apnea (OSA), has scheduled the release of its fourth quarter and financial year 2024 results on March 13, 2025.
The company will host a conference call with management to discuss the financial results on the same day at 1:00pm CET / 8:00am ET. Investors can access the webcast through the company's Investor Relations page or participate in the Q&A session by registering for the earnings call at least 10 minutes before the start time.
Nyxoah (Euronext Brussels/Nasdaq: NYXH), a pioneer in Obstructive Sleep Apnea (OSA) treatment through neuromodulation, has announced its participation in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference scheduled for March 17-20, 2025.
CEO Olivier Taelman will deliver a corporate presentation on Monday, March 17, 2025, at 8:40am ET. The presentation will be accessible via webcast in the Events section of Nyxoah's Investor Relations website. The company will also be available for one-on-one meetings with institutional investors during the conference.
Nyxoah (NYXH) has announced the commercial launch of its Genio system in the Middle East, marking a significant expansion of its neurostimulation therapy for Obstructive Sleep Apnea (OSA). The launch was highlighted by the first successful Genio implant at Saudi German Hospital in Dubai, UAE, performed by Dr. Ahmed Yassin Bahgat, Consultant Otolaryngologist.
This milestone represents the first-ever neurostimulation therapy for OSA in the Middle East region. The Genio system is designed as an alternative treatment for OSA patients who cannot tolerate CPAP therapy. The company emphasizes the system's innovative, clinically proven capabilities and its patient-centric approach.
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