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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 (NYXH) has successfully raised $27 million through its at-the-market (ATM) offering, selling 3 million shares to a single U.S.-based healthcare investor. The shares were sold at market price on the Nasdaq Global Market, with Cantor Fitzgerald & Co. acting as the sales agent. This transaction was conducted under Nyxoah's $50 million ATM program and its shelf registration statement on Form F-3.
CEO Olivier Taelman emphasized that this investment reinforces Nyxoah's U.S. focus and strengthens its financial position as the company prepares for the launch of Genio® in the United States. The funding follows the presentation of compelling DREAM pivotal study data at the International Surgical Sleep Society (ISSS) congress and aligns with Taelman's recent relocation to the U.S.
Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) has released information on its total number of voting rights and shares as of September 27, 2024, in compliance with Belgian law. The company's share capital stands at EUR 5,907,711.21, with a total of 34,389,015 securities carrying voting rights, all of which are ordinary shares. The total number of voting rights is also 34,389,015.
Additionally, Nyxoah reports 2,040,231 rights to subscribe to securities carrying voting rights not yet issued. This figure excludes 643,394 subscription rights that have been issued but not yet granted. The disclosure is part of the company's regulatory obligations regarding the transparency of large shareholdings.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) received a transparency notification from BlackRock, Inc. on September 24, 2024. The notification indicates that BlackRock Advisors, went below the 3% threshold on September 20, 2024. As of that date, BlackRock, Inc. and its controlled undertakings held 1,116,421 voting rights, representing 3.25% of the total voting rights (34,373,015).
The notification details include:
- 1,043,221 shares and 73,200 equivalent financial instruments
- BlackRock Advisors, holding 2.96% of voting rights
- BlackRock Fund Advisors, BlackRock Investment Management (UK) , and BlackRock Investment Management, holding smaller percentages
The full chain of controlled undertakings and additional information about the disclosure obligation are provided in the press release.
Nyxoah SA (NYXH), a medical technology company focused on innovative solutions for Obstructive Sleep Apnea (OSA), has announced its participation in three upcoming investor conferences in New York City. The company's CEO, Olivier Taelman, will deliver corporate updates at:
- Baird Global Healthcare Conference on September 10, 2024, at 12:15pm ET
- H.C. Wainwright 26th Annual Global Investment Conference on September 11, 2024, at 11:00am ET
- Cantor Global Healthcare Conference on September 18, 2024, at 1:55pm ET
Webcasts of the presentations will be available on Nyxoah's Investor Relations website. The company will also be available for one-on-one meetings with institutional investors attending these events.
Nyxoah SA (NYXH) celebrated its progress towards U.S. market entry by ringing the Nasdaq Closing Bell on August 29, 2024. The company, focused on innovative solutions for Obstructive Sleep Apnea (OSA), has completed its FDA regulatory submission for the Genio® device. Nyxoah is on track for U.S. approval by the end of 2024 and plans a commercial launch in early 2025.
Key highlights include:
- Positive data from the pivotal DREAM study in spring 2024
- Final module submitted for FDA review
- U.S. commercial team established, led by new CCO Scott Holstine
- Over €85 million raised to fund U.S. launch
Nyxoah SA (NYXH) reported its Q2 and H1 2024 financial results. Key highlights include:
- Completed FDA regulatory submission, with U.S. approval expected by end of 2024
- Raised over €85 million in growth capital
- Q2 2024 sales of €0.8 million
- H1 2024 sales growth of 29% year-over-year
- Total cash position of €77.8 million at quarter-end
The company is focusing on U.S. commercial readiness, with key leadership appointments made. Nyxoah's cash runway extends into mid-2026, fully funding the U.S. launch. Q2 operating loss was €13.3 million, driven by increased R&D spending and ongoing commercial and clinical activities.
Nyxoah SA (NYXH), a medical technology company focused on innovative solutions for Obstructive Sleep Apnea (OSA), has announced the release of its second quarter and first half 2024 financial results on August 6, 2024, after market close. The company will host a conference call to discuss the financial results on the same day at 10:30pm CET / 4:30pm ET.
Investors and interested parties can access the earnings call webcast through the Investor Relations page of Nyxoah's website or via a provided link. Those planning to ask questions during the call are advised to register separately using a different link. Registration is recommended at least 10 minutes before the call starts to ensure proper connection. An archived version of the webcast will be available for replay shortly after the call concludes.
Nyxoah SA (NYXH) has appointed Scott Holstine as Chief Commercial Officer to lead the company's commercial operations and enable a successful U.S. launch of its Obstructive Sleep Apnea (OSA) treatment. Holstine brings 26 years of experience in the medical device industry, with expertise in U.S. product launches and building commercial organizations. The appointment is important as Nyxoah expects FDA approval by the end of 2024 and aims to have a fully operational commercial team by year-end.
CEO Olivier Taelman emphasized the importance of this hire in accelerating Nyxoah's U.S. go-to-market strategy. Holstine, a West Point graduate with an MBA from the University of Minnesota, expressed enthusiasm about joining Nyxoah, citing the company's strong DREAM study results and Genio's success in markets outside the U.S. as indicators of the technology's potential in the Hypoglossal Nerve Stimulation (HGNS) field.
On July 3, 2024, Nyxoah announced a €37.5 million loan agreement with the European Investment Bank (EIB), supported by the European Commission’s InvestEU program. The funding will facilitate research and development and scale up manufacturing to meet demands in Europe and the U.S. The loan is divided into three tranches: €10 million, €13.75 million, and €13.75 million, each carrying a 5% cash and 5% capitalized interest rate with a five-year repayment schedule.
Conditions apply for fund disbursement, and a synthetic warrant agreement is intended, granting EIB synthetic warrants based on tranche-specific formulas. Each tranche's maturity determines warrant exercise dates, with initial expectations for 468,384 synthetic warrants for Tranche A at an €8.11 strike price. The loan agreement and synthetic warrant terms tied to control changes will be submitted for shareholder approval.
CEO Olivier Taelman highlighted the combined access to over €80 million in capital, emphasizing the support’s role in commercializing Genio and expanding production.
Nyxoah, a medical technology company, announced the submission of the fourth and final module of its Premarket Approval (PMA) application for the Genio system to the U.S. FDA. Genio, a non-implanted, leadless HGNS solution, treats Obstructive Sleep Apnea (OSA) and offers patients a fully-body MRI compatible, wearable-powered device. The DREAM U.S. pivotal study showed significant reductions in the 12-month AHI and ODI responder rates. Plans for a U.S. launch by the end of 2024 are underway, with complete DREAM data to be presented in September at the International Surgical Sleep Society meeting.
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