Latest news with #Genio®
Bahrain News Gazette
08-05-2025
- Business
- Bahrain News Gazette
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025 Mont-Saint-Guibert, Belgium – Wednesday May 7, 2025, 10:30pm CET / 4:30pm 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 first quarter of 2025 on Wednesday, May 14, 2025. Company management will host a conference call to discuss financial results that day beginning 2:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2025 Earnings Call Webcast . For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q1 2025 Earnings Call . After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Q1 Earnings Call Announcement_FINAL GlobeNewswire Distribution ID 1001095238
Business Insider
21-04-2025
- Business
- Business Insider
Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Nyxoah S.A. (NYXH) and Encourages Shareholders to Learn More About the Investigation
NEW YORK CITY, NY / ACCESS Newswire / April 21, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Nyxoah S.A. ("Nyxoah" or "the Company") (NASDAQ:NYXH). Investors who purchased Nyxoah securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: Investigation Details On March 25, 2025, Nyxoah issued a press release "announcing 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", adding that the 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 … and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review." Analysts noted that the Company's announcement will likely result in a delay in Genio's commercial launch. Following this news, Nyxoah stock dropped more than 21.3% the next day. What's Next? If you are aware of any facts relating to this investigation or purchased Nyxoah securities, you can assist this investigation by visiting the firm's site: You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660 There is No Cost to You We represent investors in class actions on a contingency fee basis. That means we will ask the court to reimburse us for out-of-pocket expenses and attorneys' fees, usually a percentage of the total recovery, only if we are successful. Why Bronstein, Gewirtz & Grossman Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide. Attorney advertising. Prior results do not guarantee similar outcomes. Contact View the original press release on ACCESS Newswire Markets Insider and Business Insider Editorial Teams were not involved in the creation of this post.
Bahrain News Gazette
08-04-2025
- Business
- Bahrain News Gazette
Nyxoah Provides Update on FDA Approvable Letter for Genio System
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 satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system. Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May. 'We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.' About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Update on FDA Approvable Letter_FINAL GlobeNewswire Distribution ID 1001078888
Associated Press
06-04-2025
- Business
- Associated Press
NYXH Investors Have Opportunity to Join Nyxoah S.A. Fraud Investigation with the Schall Law Firm
The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nyxoah S.A. ('Nyxoah' or 'the Company') (NASDAQ: NYXH) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Nyxoah issues a press release on March 25, 2025, 'announcing 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', adding that the 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 … and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review.' Analyst noted that the Company's announcement will likely result in a delay in Genio's commercial launch. Based on this news, shares of Nyxoah fell by more than 21.3% on the next day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. Brian Schall, Esq. 310-301-3335 SOURCE: The Schall Law Firm Copyright Business Wire 2025. PUB: 04/05/2025 07:48 PM/DISC: 04/05/2025 07:47 PM
Bahrain News Gazette
26-03-2025
- Business
- Bahrain News Gazette
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATION REGULATED 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, 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 satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients. 'The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA's Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We are still on the right track to make Genio available to U.S. patients suffering from OSA.' This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_FDA Approvable Press Release GlobeNewswire Distribution ID 1001076080
