The guidance cut signals slower-than-expected U.S. commercial ramp despite sequential growth. Watch for the FDA's decision on the PMA supplement for CCC indication, which could expand the addressable patient population and accelerate adoption.
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Executive Summary
Nyxoah reported preliminary Q3 2026 global net revenue of €9.2 million (up 19% sequentially) and U.S. net revenue of €6.7 million (up 29% sequentially), while lowering full-year 2026 revenue guidance to €33-35 million from €36-40 million. The company also submitted a PMA supplement to the FDA to expand Genio's U.S. indication to Complete Concentric Collapse patients, supported by positive ACCCESS study results.
Key Facts
- Global preliminary net revenue of €9.2 million in Q3 2026, up 19% sequentially
- U.S. net revenue of €6.7 million in Q3 2026, up 29% sequentially
- Full-year 2026 revenue guidance lowered to €33-35 million from €36-40 million
- PMA supplement submitted to FDA to expand Genio's U.S. indication to CCC patients
- ACCCESS study met co-primary efficacy endpoints with 12-month AHI responder rate of 77.2% (p<0.001) and zero device- or procedure-related serious adverse events
- Cash, cash equivalents and financial assets of approximately €77.0 million as of September 30, 2026
- 80 new surgeons trained in Q3 (total 342), 53 new accounts activated (total 233), 447 patients under prior authorization entering Q4
Financial Impact
Revenue guidance reduced by €3-5 million at the midpoint (from €38 million to €34 million), a ~10.5% cut
Risk Factors
- Slower-than-expected U.S. revenue growth trajectory
- FDA review outcome and timing for PMA supplement
- Cash burn rate given €77 million cash position and need to fund commercialization
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001104659-26-117415 |
| Document: tm2627823d1_6k.htm | 0001104659-26-117415 |
| Document: 0001104659-26-117415-index-headers.html | 0001104659-26-117415 |
| Document: 0001104659-26-117415-index.html | 0001104659-26-117415 |
| Document: 0001104659-26-117415.txt | 0001104659-26-117415 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 6-K | $0.8950 $0.8220 | ▲ +8.16% | ▲ +6.98% | $0.9089 (−1.55%) |
Oct 19, 2026 8d ago | Press Release | $0.9540 $0.9400 | ▲ +1.47% | ▲ +1.80% | $0.9089 (+4.73%) |
Sep 22, 2026 4w ago | 6-K | $1.33 $1.27 | ▼ −4.51% | ▼ −4.43% | $0.9089 (−31.66%) |
Jun 23, 2026 17w ago | 6-K | $1.62 $1.63 | ▼ −0.62% | ▼ −0.47% | $0.9089 (+43.90%) |
Jun 11, 2026 19w ago | 6-K | $1.39 $1.55 | ▼ −11.51% | ▼ −9.75% | $0.9089 (+34.61%) |
Jun 8, 2026 20w ago | 6-K | $1.34 $1.31 | ▲ +2.24% | ▲ +0.66% | $0.9089 (+32.17%) |
Jun 8, 2026 20w ago | 424B5 | $1.39 $1.34 | ▲ +3.60% | ▲ +3.30% | $0.9089 (+34.61%) |
Jun 5, 2026 20w ago | Press Release | $1.45 $1.39 | ▲ +4.14% | ▲ +4.36% | $0.9089 (+37.32%) |
Jun 4, 2026 20w ago | 424B5 | $1.45 $1.39 | ▲ +4.14% | ▲ +4.36% | $0.9089 (+37.32%) |
May 20, 2026 22w ago | Press Release | $2.87 $2.87 | · 0.00% | ▼ −0.45% | $0.9089 (−68.33%) |
US Market Status
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