Nyxoah SA NYXH
Nyxoah SA (Nasdaq: NYXH) is a medical device company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Genio system | obstructive sleep apnea (PMA approved US Aug 2025; CE-marked) | — | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 20, 2026met ACCCESS U.S. pivotal study met co-primary efficacy endpoints with 77.2% AHI responder rate and zero serious adverse events in Complete Concentric Collapse patients.
ACCCESS U.S. pivotal study met its co-primary efficacy endpoints and its safety endpoints in Complete Concentric Collapse (CCC) patients, with a 12-month AHI responder rate of 77.2% (p<0.001) and zero device- and procedure-related serious adverse events
Filing - Oct 20, 2026submitted Submitted a PMA supplement to the FDA to expand Genio's U.S. indication to Complete Concentric Collapse patients under Breakthrough Device Designation.
Submitted a premarket approval (PMA) supplement to the FDA to expand Genio's U.S. indication to CCC patients under Breakthrough Device Designation
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.