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Nyxoah enrolls first patient in U.S. post-approval Genio study

Mon, 07 Sep 2026 17:53:59 -0400

Nyxoah SA (Nasdaq: NYXH) announced that the first patient has been implanted in BREATHE, its U.S. post-approval study of the Genio system, a hypoglossal nerve stimulation device for obstructive sleep apnea.

The procedure was performed by Rolando Molina, MD, an otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, a sleep medicine physician at PharmaDev Clinical Research Institute in Miami, Florida, serves as the site principal investigator.

BREATHE is a multicenter, prospective, single-arm study designed to assess the long-term safety and effectiveness of the Genio system in adults with moderate to severe obstructive sleep apnea. The study plans to enroll up to

Nyxoah Announces First Patient Implanted in BREATHE, the U.S. Post-Approval Study of the Genio® System

Mon, 07 Sep 2026 16:05:00 -0400

Nyxoah Announces First Patient Implanted in BREATHE, the U.S. Post-Approval Study of the Genio^® System

BREATHE is scheduled to implant up to 229 patients at up to 25 U.S. centers, followed for up to five years, to evaluate the long-term safety and effectiveness of the Genio therapy in real-world clinical practice

First implant performed by Rolando Molina, MD, South Florida ENT Associates, with Edward Mezerhane, MD, of PharmaDev Clinical Research Institute as Site Principal Investigator

Mont-Saint-Guibert, Belgium – September 7, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq:

Nyxoah Announces First Patient Implanted in BREATHE, the U.S. Post-Approval Study of the Genio® System

Mon, 07 Sep 2026 16:05:00 -0400

Nyxoah Announces First Patient Implanted in BREATHE, the U.S. Post-Approval Study of the Genio^® System

BREATHE is scheduled to implant up to 229 patients at up to 25 U.S. centers, followed for up to five years, to evaluate the long-term safety and effectiveness of the Genio therapy in real-world clinical practice

First implant performed by Rolando Molina, MD, South Florida ENT Associates, with Edward Mezerhane, MD, of PharmaDev Clinical Research Institute as Site Principal Investigator

Mont-Saint-Guibert, Belgium – September 7, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq:

Nyxoah SA (NYXH) Reiterated at Overweight by Cantor Fitzgerald on Label Expansion Potential

Fri, 04 Sep 2026 07:21:57 -0400

Cantor Fitzgerald analyst Sarah James reiterated an Overweight rating and $6.00 price target on Nyxoah SA (NASDAQ: NYXH).
The analyst commented, "NYXH's ACCCESS U.S. Pivotal Study achieved its 12-month primary endpoints, keeping it on track for late-3Q26/early-4Q26 PMA submission & if successful, label expansion in late-1Q27/early-2Q27. It plans to present the complete 12-month dataset and detailed results at ISSS on 10/15-16, but today (09/03) shared a 77.2% AHI respondent rate and 0 device-related serious adverse events. We are reiterating our Overweight rating & $6.00 price target, driven by our confidence in label expansion."
For an analyst ratings summary and ratings history

Nyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse Patients

Wed, 02 Sep 2026 16:05:00 -0400

REGULATED INFORMATION
INSIDE INFORMATION

Nyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse Patients

Reports an Apnea-Hypopnea Index (AHI) responder rate of 77.2% on a Full Analysis Set basis (p<0.001)

Zero device-related serious adverse events through 12 months

Mont-Saint-Guibert, Belgium – September 2, 2026, 10:05 pm CET / 4:05 pm 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 that the ACCCESS U.S.

Nyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse Patients

Wed, 02 Sep 2026 16:05:00 -0400

REGULATED INFORMATION
INSIDE INFORMATION

Nyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse Patients

Reports an Apnea-Hypopnea Index (AHI) responder rate of 77.2% on a Full Analysis Set basis (p<0.001)

Zero device-related serious adverse events through 12 months

Mont-Saint-Guibert, Belgium – September 2, 2026, 10:05 pm CET / 4:05 pm 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 that the ACCCESS U.S.

Nyxoah SA (NYXH) PT Lowered to $6 at Cantor Fitzgerald to Reflect Current Trading Levels

Mon, 17 Aug 2026 08:11:12 -0400

Cantor Fitzgerald analyst Sarah James lowered the price target on Nyxoah SA (NASDAQ: NYXH) to $6.00 (from $11.00) while maintaining an Overweight rating.
The analyst commented, "NYXH advanced its U.S. commercialization strategy while upholding best-in-class prior authorization. It activated 89 new accounts in 2Q26 (now 180 high-volume HGNS accounts) and added 55 new surgeons. It remains optimistic in its capacity to capture 10-15% market share over 12 months, which was the threshold that drove it towards breakeven in Germany. Management noted that in some regions it has well exceeded this, capturing up to 40% market share. We are lowering our price

Nyxoah SA (NYXH) PT Lowered to $6 at Cantor Fitzgerald to Reflect Current Trading Levels

Mon, 17 Aug 2026 08:11:12 -0400

Cantor Fitzgerald analyst Sarah James lowered the price target on Nyxoah SA (NASDAQ: NYXH) to $6.00 (from $11.00) while maintaining an Overweight rating.
The analyst commented, "NYXH advanced its U.S. commercialization strategy while upholding best-in-class prior authorization. It activated 89 new accounts in 2Q26 (now 180 high-volume HGNS accounts) and added 55 new surgeons. It remains optimistic in its capacity to capture 10-15% market share over 12 months, which was the threshold that drove it towards breakeven in Germany. Management noted that in some regions it has well exceeded this, capturing up to 40% market share. We are lowering our price

Form SCHEDULE 13G/A Nyxoah SA Filed by: CVI Investments, Inc.

Fri, 14 Aug 2026 14:45:00 -0400
si-local-file:///var/storage/secattach/20260814/26929156.html

Form SCHEDULE 13G/A Nyxoah SA Filed by: CVI Investments, Inc.

Fri, 14 Aug 2026 14:45:00 -0400
si-local-file:///var/storage/secattach/20260814/26929156.html

Form SCHEDULE 13G/A Nyxoah SA Filed by: CVI Investments, Inc.

Fri, 14 Aug 2026 14:45:00 -0400
si-local-file:///var/storage/secattach/20260814/26929156.html

Nyxoah SA (NYXH) PT Lowered to $4 at Oppenheimer

Thu, 06 Aug 2026 08:37:39 -0400
Oppenheimer analyst Suraj Kalia lowered the price target on Nyxoah SA (NASDAQ: NYXH) to $4.00 (from $13.00) while maintaining a Outperform rating.

Nyxoah SA (NYXH) PT Lowered to $6 at Piper Sandler

Thu, 06 Aug 2026 07:13:45 -0400
Piper Sandler analyst Adam Maeder lowered the price target on Nyxoah SA (NASDAQ: NYXH) to $6.00 (from $7.00) while maintaining a Overweight rating.

Nyxoah S.A. (NYXH) Misses Q2 EPS by 13c

Thu, 06 Aug 2026 01:53:12 -0400

Nyxoah S.A. (NASDAQ: NYXH) reported Q2 EPS of (EUR0.58), EUR0.13 worse than the analyst estimate of (EUR0.45). Revenue for the quarter came in at EUR7.67 million versus the consensus estimate of EUR8.8 million.
For earnings history and earnings-related data on Nyxoah S.A. (NYXH) click here.

Form 6-K Nyxoah SA For: Jun 30

Wed, 05 Aug 2026 16:13:00 -0400
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Form 6-K Nyxoah SA For: Jun 30

Wed, 05 Aug 2026 16:13:00 -0400
si-local-file:///var/storage/secattach/20260805/26874485.html

Form 6-K Nyxoah SA For: Jun 30

Wed, 05 Aug 2026 16:13:00 -0400
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Form 6-K Nyxoah SA For: Jul 09

Thu, 09 Jul 2026 16:30:00 -0400
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Form 6-K Nyxoah SA For: Jul 09

Thu, 09 Jul 2026 16:30:00 -0400
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Form 6-K Nyxoah SA For: Jul 09

Thu, 09 Jul 2026 16:30:00 -0400
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Nyxoah SA (NYXH) Reiterated at Hold by Stifel: Will Breakeven in '2028 if Not Sooner'

Thu, 09 Jul 2026 07:09:15 -0400

Stifel analyst Jonathan Block reiterated a Hold rating and $3.00 price target on Nyxoah SA (NASDAQ: NYXH).
The analyst commented, "We addressed Nyxoah’s 2Q26 preannouncement last night, so we focus on the (limited) incremental takeaways from the Investor Day. The most helpful color was likely specific to the path for Inspire Medical to obtain a specific HGNS code starting in 2028, rather than any incremental information that would alter our cautious stance on Nyxoah.In short, we view the company’s €150MM breakeven revenue aspiration (for 2028, if not sooner), 80% GM (from 61% LTM), and only measured increases in opex as best

Nyxoah SA (NYXH) Reiterated at Hold by Stifel as More Share Dilution Expected

Wed, 08 Jul 2026 07:38:03 -0400

Stifel analyst Jonathan Block reiterated a Hold rating and $3.00 price target on Nyxoah SA (NASDAQ: NYXH).
The analyst commented, "While 2026 Street estimates most likely remain unchanged following 2Q26 top-line results, they are not moving higher, and Nyxoah’s march toward cash flow breakeven remains at least a couple of years away, in our opinion. Our estimates already appear aggressive (see bullet below), with our 2028E reflecting Genio capturing 40% of the incremental HGNS market. Management is assuming an even steeper ramp.Recall, our May 2026 downgrade made the case that $200MM+ in additional capital will be needed for Nyxoah to reach

Form SCHEDULE 13G/A Nyxoah SA Filed by: RESMED INC

Wed, 01 Jul 2026 07:00:00 -0400
si-local-file:///var/storage/secattach/20260701/26716679.html

Form SCHEDULE 13G/A Nyxoah SA Filed by: RESMED INC

Wed, 01 Jul 2026 07:00:00 -0400
si-local-file:///var/storage/secattach/20260701/26716679.html

Form SCHEDULE 13G/A Nyxoah SA Filed by: RESMED INC

Wed, 01 Jul 2026 07:00:00 -0400
si-local-file:///var/storage/secattach/20260701/26716679.html