Nyxoah shares fall after CFO departure announcement

Nyxoah SA (NYXH) presented 12-month data from its ACCCESS study on the Genio system for sleep apnea, meeting efficacy endpoints. AHI responder rate was 77.2%, ODI 87.7%. No device-related serious adverse events occurred. The company submitted a PMA supplement to the FDA to expand the Genio system's indication.

Nyxoah SA reported 12-month ACCCESS data showing a 74.3% median AHI reduction with Genio in CCC OSA patients. The company filed a PMA supplement with the FDA to expand Genio’s indication to CCC patients, with no serious adverse events reported. According to Nyxoah, a positive FDA decision could be a significant commercial catalyst.

Nyxoah SA (NYXH) shares rose 11.9% after its ACCCESS U.S. study met primary safety and efficacy endpoints. The Genio system showed a 77.2% Apnea-Hypopnea Index responder rate and zero device-related serious adverse events. The company plans to submit a premarket approval supplement to the FDA for expanded indication.

Nyxoah SA (NYXH) reported positive results from its ACCCESS trial for the Genio system in treating sleep apnea with Complete Concentric Collapse (CCC). The study met primary efficacy and safety endpoints, with 77.2% AHI responder rate and 87.7% ODI responder rate. NYXH shares rose 29.14% in overnight trading.

Nyxoah SA (NYXH) furnished an SEC Form 6-K — earnings release. ​ Exhibit 99.1 REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026 Mont-Saint-Guibert, Belgium –

Nyxoah SA (NYXH) reported Q2 2026 net revenue of €7.7 million, up from €1.3 million a year earlier, with U.S. net revenue €5.2 million, 22% higher sequentially. First-half 2026 net revenue was €14.0 million. The company secured $110 million financing, had €97.8 million cash at June 30, and guided FY2026 revenue €36-40 million and gross margin 60-62%.