Nyxoah SA NYXH

Nasdaq · EDGAR · Updated Nov 6, 2026

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.

Program	Indication	Modality	Stage
Genio system	obstructive sleep apnea (PMA approved US Aug 2025; CE-marked)	—	NA_NON_THERAPEUTIC

Nov 5, 2026
submitted PMA supplement submitted to FDA to expand Genio system indication to include CCC patients.The Company is preparing a PMA supplement submission to the FDA to expand the Genio system indication to CCC patients. Filing
Oct 20, 2026
met 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, 2026
submitted 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

3 more on record.

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