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Nyxoah SA

NYXHFDA catalysts, PDUFA dates & pipeline intelligence
$1.35
▼ -0.07 · -4.93%

Financials

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52W LOW $1.2652W HIGH $6.87
Volume
88.04 K
Value Traded
176.31 K
Short % Float
0.33%
-0.74%Week
-11.18%1 Month
-21.05%3 Month
-52.8%6 Month
-87.6%5 Year
-88.04%All Time

Cash Data

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Key Stats

Market Cap
137.48 M
EPS (TTM)
-2.47
P/E Ratio
-
Ent. Value
139.99 M
Total Shares
101.84 M
Float Shares
81.29 M
Insiders
20.18%
Institutions
23.68%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

NYXH Catalyst Timeline

Dated clinical, regulatory and corporate events for Nyxoah SA

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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How NYXH actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

No drug pipeline

Nyxoah SA is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every NYXH program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Genio
Breakthrough
Complete Concentric Collapse (CCC) of the soft palate2026-09-02AHI responder rate: 77.2%; ODI responder rate: 87.7%; serious adverse events: zeroRead MoreNyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse PatientsRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
John SmithCEOBuy 50,000 150,000 held$45.50 01/10/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Ikarian Capital, LLC 0 % 80.00 K 47.36 K
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NYXH Institutional Ownership Trends

Options Data

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Option Chain Statistics

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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How NYXH ranks across every disease it competes in

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See how NYXH ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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NYXH News

NYXH
Sep 28, 2026
NYXHGeneral
▼ -13.8%on this news

Nyxoah Nomme Liam Kelly au Poste de Chief Executive Officer

Nyxoah has appointed Liam Kelly as the new Chief Executive Officer, effective October 1, 2026, succeeding Olivier Taelman. This leadership change is part of Nyxoah's strategy to enhance its presence in the U.S. market following FDA approval and the launch of its Genio system. Kelly's extensive experience in the MedTech sector is expected to drive growth and value creation for the company.

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NYXH
Sep 28, 2026
NYXHGeneral
▼ -13.8%on this news

Nyxoah Appoints Liam Kelly as Chief Executive Officer

Nyxoah has appointed Liam Kelly as the new Chief Executive Officer, effective October 1, 2026. This decision aligns with the company's strategy to enhance its presence in the U.S. market following FDA approval of its Genio system for Obstructive Sleep Apnea. Kelly brings over 25 years of leadership experience in the medical technology sector.

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NYXH
Sep 21, 2026
NYXHGeneral
▼ -5.4%on this news

Nyxoah Announces Chief Financial Officer Transition

Nyxoah has announced a transition in its Chief Financial Officer position, with Loïc Moreau stepping in as interim CFO following John Landry's departure. The company reaffirms its financial guidance for 2026, expecting net revenue between €36 million and €40 million. Moreau's prior experience as CFO is expected to facilitate a smooth transition.

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NYXH
Sep 7, 2026
NYXHPhases

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

Nyxoah has successfully implanted the first patient in the BREATHE study, a U.S. post-approval trial for its Genio® system aimed at treating obstructive sleep apnea. The study will involve up to 229 patients across 25 centers and will assess the therapy's long-term safety and effectiveness over five years. This marks a significant advancement in sleep medicine and neurostimulation therapy.

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NYXH
Sep 2, 2026
NYXHPhases
▲ +16.6%on this newsshared move

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

Nyxoah announced that its ACCCESS U.S. pivotal study for the Genio system met primary safety and efficacy endpoints for patients with Complete Concentric Collapse (CCC) of the soft palate. The study reported a 77.2% AHI responder rate and zero serious adverse events over 12 months. The company plans to submit a premarket approval supplement to the FDA to expand Genio's indication for CCC patients.

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NYXH
Aug 5, 2026
NYXHGeneral
▼ -7.1%on this news

Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results

Nyxoah SA reported strong financial results for Q2 and the first half of 2026, with U.S. net revenue growing by 22% sequentially. The company secured €110 million in financing and achieved a 100% approval rate for prior authorization submissions. However, it also experienced an increase in operating losses and a decrease in gross margin due to a higher mix of U.S. revenue.

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NYXH
Jul 27, 2026
NYXHConferences/Events

Nyxoah to Release Second Quarter 2026 Financial Results on August 5, 2026

Nyxoah SA announced it will release its financial results for Q2 2026 on August 5, 2026. A conference call will follow to discuss these results. The company, known for its innovative treatment for Obstructive Sleep Apnea, has seen recent successes including FDA approval and positive study outcomes. Investors can access the call via a webcast.

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NYXH
Jul 7, 2026
NYXHGeneral

Nyxoah Announces Preliminary Results for the Second Quarter of 2026

Nyxoah SA reported preliminary results for Q2 2026, highlighting a global net revenue of approximately €7.7 million, marking a 21% increase from the previous quarter. The U.S. revenue also showed strong growth at €5.2 million, with 55 new surgeons trained and 89 new accounts activated. Additionally, proposed reimbursement increases from CMS for the Genio procedure are expected to enhance economic value. The company secured $110 million in financing, positioning it for accelerated growth.

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NYXH
Jun 23, 2026
NYXHConferences/Events

Nyxoah Organisera une Journée Investisseurs à New York le 8 juillet 2026

Nyxoah SA will host an Investor Day on July 8, 2026, in New York, focusing on its business execution in the U.S. and growth strategy. The event will be held at Bank of America and will include discussions on the Genio system's market dynamics and reimbursement environment. A live webcast will be available for remote participants.

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NYXH
Jun 23, 2026
NYXHConferences/Events

Nyxoah to Host Investor Day in New York on July 8, 2026

Nyxoah SA will host an Investor and Analyst Day on July 8, 2026, in New York. The event will focus on the company's U.S. commercial execution, growth strategy, and key priorities, including the Genio system's market dynamics and reimbursement landscape. Participants will include Nyxoah's leadership and external clinical experts.

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NYXH
Jun 17, 2026
NYXHGeneral

Nyxoah Reçoit 15 Millions de Dollars de la Banque Européenne d’Investissement

Nyxoah SA has secured $15 million from the European Investment Bank, completing a total capital raise of $110 million. This funding will primarily support the commercial launch of its Genio system in the U.S. and further investments in R&D. The non-dilutive nature of the financing strengthens the company's balance sheet without affecting existing shareholders.

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NYXH
Jun 17, 2026
NYXHGeneral

Nyxoah Receives $15 Million from the European Investment Bank

Nyxoah has successfully drawn $15 million from the European Investment Bank, contributing to a total of $110 million raised in June 2026. This funding will primarily support the U.S. launch of their Genio system, a treatment for Obstructive Sleep Apnea. The non-dilutive nature of this financing enhances the company's financial position without affecting existing shareholders.

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NYXH
Jun 15, 2026
NYXHGeneral

La Thérapie Genio® de Nyxoah Remporte le Prix Galien UK 2026 de la Meilleure Technologie Médicale

Nyxoah SA's Genio® therapy for obstructive sleep apnea has won the Galien UK 2026 award for Best Medical Technology. This award is a significant recognition of the advancements made in treating obstructive sleep apnea, a condition affecting millions. The CEO emphasized the collective effort behind this success, which reflects the commitment to improving patient care. The company is also expanding its market presence following FDA approval.

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NYXH
Jun 15, 2026
NYXHGeneral

Nyxoah’s Genio® Wins Prix Galien UK 2026 Award for Best Medical Technology

Nyxoah's Genio® has been awarded the Prix Galien UK 2026 Award for Best Medical Technology, recognizing its innovative hypoglossal nerve stimulation therapy for Obstructive Sleep Apnea (OSA). This award underscores the technology's impact on patient care and the ongoing efforts of Nyxoah's team and healthcare partners. The company is also expanding its market presence following FDA approval and new financing.

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NYXH
Jun 10, 2026
NYXHGeneral

Information on the total number of voting rights and shares

Nyxoah SA has disclosed information regarding its total number of voting rights and shares following the issuance of 55,232,558 new shares. This issuance was part of an underwritten public offering in the United States, which included private offerings to institutional investors. The move demonstrates Nyxoah's strategy to enhance its capital base while engaging the investment community.

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NYXH
Jun 10, 2026
NYXHGeneral

Nyxoah Announces Closing of Underwritten Public Offering

Nyxoah SA has successfully closed an underwritten public offering, raising about $95 million through the sale of over 55 million shares at $1.72 each. The company plans to utilize the proceeds to expand its commercialization efforts in the U.S., enhance R&D for its Genio system, and support ongoing clinical research. This move is part of Nyxoah's strategy to strengthen its position in the Obstructive Sleep Apnea market.

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NYXH
Jun 5, 2026
NYXHGeneral
▼ -49.7%on this newsshared move

Nyxoah Announces Pricing of $95 Million Underwritten Public Offering

Nyxoah SA has announced the pricing of a $95 million underwritten public offering, selling 55,232,558 ordinary shares at $1.72 each. The proceeds will be utilized for expanding commercialization efforts in the U.S., advancing R&D for the Genio system, and general corporate purposes. The offering is anticipated to close on June 9, 2026.

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NYXH
Jun 4, 2026
NYXHGeneral

Nyxoah Enters New Chapter of Long Term Value Creation

Nyxoah has announced a leadership transition to appoint a U.S.-based CEO, aiming to enhance its commercial efforts for the Genio system in the U.S. market. Olivier Taelman, the current CEO, will assist during the transition while the company seeks a new leader. This change is expected to support Nyxoah's growth in the expanding Obstructive Sleep Apnea market.

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NYXH
Jun 4, 2026
NYXHGeneral

Nyxoah Entre dans une Nouvelle Phase de Création de Valeur à Long Terme

Nyxoah is initiating a leadership transition to appoint a US-based CEO to accelerate its commercial launch of the Genio system in the US market. Olivier Taelman, the current CEO, will remain involved during the transition period. The company aims to leverage enhanced financial resources and a focused US leadership structure for its growth in the obstructive sleep apnea market.

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NYXH
Jun 4, 2026
NYXHGeneral

Nyxoah Announces Proposed Offering of Ordinary Shares

Nyxoah SA has announced a proposed underwritten public offering of ordinary shares in the U.S. to fund commercialization and R&D for its Genio system, aimed at treating Obstructive Sleep Apnea. The offering includes a potential 30-day option for underwriters to purchase additional shares. The company has received regulatory approvals for its innovative therapy, but the offering's completion is contingent on market conditions.

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About Nyxoah SA

154 employees nyxoah.com
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