Biopharma Transcript

Nyxoah SA NYXH

Nasdaq · EDGAR · Updated Oct 24, 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.

Pipeline

ProgramIndicationModalityStage
Genio systemobstructive sleep apnea (PMA approved US Aug 2025; CE-marked)—NA_NON_THERAPEUTIC

Recent results and decisions

  1. 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
  2. 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

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