Welcome to our dedicated page for Nyxoah SA news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on Nyxoah SA stock.
Nyxoah SA reports medical-technology developments tied to the Genio system, its patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea. Company news commonly covers financial and operating results, U.S. commercialization activity, regulatory status, manufacturing capacity, reimbursement references, investor conference participation, and the development and commercialization of OSA treatment alternatives.
Nyxoah also publishes regulated information for its Euronext Brussels and Nasdaq securities, including transparency notifications, shareholder-meeting materials, voting-right disclosures, and bond-related capital-structure notices.
Nyxoah (NYXH) reported implantation of the first patient in BREATHE, its U.S. post-approval study of the Genio® hypoglossal nerve stimulation system for obstructive sleep apnea.
BREATHE is a multicenter, prospective, single-arm study in adults with moderate to severe OSA, planning to implant up to 229 patients at up to 25 U.S. centers with follow-up for up to five years. Co-primary effectiveness endpoints are Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months, while safety endpoints track device- and procedure-related serious adverse events at 12 months and annually thereafter. The company said BREATHE will build long-term, real-world evidence for Genio in routine clinical practice.
Nyxoah (NYXH) reported that its ACCCESS U.S. pivotal study in Complete Concentric Collapse (CCC) patients met all co-primary safety and efficacy endpoints at 12 months for the Genio hypoglossal nerve stimulation system.
The Full Analysis Set of 47 implanted and activated patients showed an Apnea-Hypopnea Index (AHI) responder rate of 77.2% and an Oxygen Desaturation Index (ODI) responder rate of 87.7%, both statistically significant (p<0.001). No device-related serious adverse events were observed through 12 months post-implant. The trial was conducted under an FDA-approved protocol, using prespecified multiple imputation for missing data. Nyxoah is preparing a premarket approval (PMA) supplement to seek expansion of Genio’s U.S. indication to CCC patients, under FDA Breakthrough Device Designation, with full 12‑month data planned for presentation at the ISSS meeting in October 2026.
Nyxoah (Euronext Brussels & Nasdaq: NYXH) reported updated capital and voting-rights data following the issuance of 1,767,402 new shares on August 20, 2026, linked to a contribution in kind of a receivable held by the holder of its December 18, 2025 convertible bonds.
According to Nyxoah, total share capital now amounts to EUR 7,092,826.33, represented by 101,840,217 ordinary shares, each carrying one voting right. The company also detailed outstanding subscription rights and 225 convertible bonds, including the maximum voting rights that could result from their conversion at specified prices.
Nyxoah (Nasdaq/Euronext: NYXH) reported Q2 2026 net revenue of €7.7 million, up from €1.3 million in Q2 2025, with U.S. net revenue of €5.2 million and 22% sequential U.S. growth. First-half 2026 net revenue reached €14.0 million versus €2.4 million a year earlier.
Q2 2026 gross margin was 60% versus 63% in Q2 2025, and operating loss was €20.6 million; net loss was €33.0 million, or €0.578 per share. The company secured $110 million in aggregate financing, ending June 30, 2026 with €97.8 million in cash, cash equivalents and financial assets. Nyxoah maintained 2026 revenue guidance of €36–40 million and gross margin of 60–62%, but raised total operating expense guidance to €99–102 million, while reiterating non-GAAP cash operating expenses of €88–90 million.
Nyxoah (Euronext Brussels/Nasdaq: NYXH) will release its second quarter 2026 financial results on Wednesday, August 5, 2026. Management will host a conference call at 10:30pm CET / 4:30pm ET to discuss the results, with live access via webcast on the Investor Relations page.
Investors who wish to ask questions must register through a dedicated earnings call link to receive dial-in details and a unique access code. Nyxoah develops the Genio hypoglossal neurostimulation system for obstructive sleep apnea, which holds a CE mark since 2019 and obtained FDA approval in August 2025.
Nyxoah (Nasdaq:NYXH) reported preliminary, unaudited Q2 2026 results, with global net revenue expected at €7.7 million, up 21% sequentially, and U.S. revenue at €5.2 million, up 22%.
The company secured $110 million in Q2 financing, ended June 30 with about €97.8 million in cash and financial assets, and reaffirmed 2026 revenue guidance of €36–40 million. CMS proposed 2027 reimbursement increases for the Genio procedure of 12% for hospital outpatient and 15% for ASC settings.
Nyxoah (Nasdaq: NYXH) reported updated share capital and voting rights as of June 30, 2026, after issuing 146,531 new shares from exercised restricted share units.
Share capital is EUR 7,075,152.31 with 100,072,815 ordinary shares and the same number of voting rights.
Nyxoah (NASDAQ:NYXH) reported two transparency notifications under Belgian disclosure rules after changes in major shareholdings as of June 10, 2026.
Entities controlled by Orin Hirchman now hold 14,534,880 voting rights, or 14.55% of Nyxoah’s 99,926,284 shares. Resmed passively moved below the 3% threshold and now holds 1,943,828 voting rights, or 1.95%.
Nyxoah (Nasdaq: NYXH) will host an Investor and Analyst Day in New York on July 8, 2026, from 10:00 AM to 12:30 PM ET at Bank of America Tower.
The event will cover U.S. Genio launch momentum, OSA market dynamics, reimbursement, and the company’s path to profitability, and will be accessible via live webcast and replay.
Nyxoah (Nasdaq:Euronext: NYXH) convenes an extraordinary shareholders’ meeting on July 9, 2026 at 2:00 p.m. CET at its registered office.
Key agenda items include renewing the board’s authorization to increase share capital for five years and granting powers to the notary. Attendance requires registration by the June 25, 2026 record date and confirmation by July 3, 2026. Shareholders may vote by mail or proxy and follow the meeting via non-voting videoconference.