Nyxoah S.A. (NASDAQ: NYXH) witnessed a remarkable surge of 25.00% in its stock during the current session, reaching $7.00. Despite the absence of noteworthy news directly influencing this spike, attention turns to recent developments that may be fueling positive investor sentiment.
In preparation for forthcoming investor meetings, Nyxoah (NYXH) disclosed its strategic priorities for 2024 last week. Notably, the company successfully concluded patient follow-up in the DREAM U.S. pivotal study and is set to release efficacy and safety data by early April. At the SLEEP 2023 event, 12-month efficacy data for the initial 34 DREAM patients and safety data for all DREAM patients were presented.
The results showcased a 65% AHI responder rate, a 76% ODI responder rate, and safety metrics in line with expectations. NYXH also submitted the fourth and final module in the modular PMA submission and plans to submit the final module shortly after announcing DREAM results.
In anticipation of a late 2024 launch, the company heightened investments in its U.S. commercial organization, appointing Francis Kim as Chief Regulatory and Quality Officer and expanding market access to secure reimbursement upon launch. Furthermore, Nyxoah successfully completed enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study.
Recently unveiled investigator-sponsored data in Europe highlighted Genio’s efficacy in treating CCC patients. Genio’s unique single-incision, leadless, upgradable design, controlled by a wearable, resonated positively with both clinicians and patients, resulting in a robust European launch.
Genio’s bilateral stimulation allows for the treatment of CCC, and the label was expanded to encompass patients who, having failed CPAP, previously had major palate surgery as their only treatment option. Nyxoah is poised on the brink of a historic milestone with the imminent release of DREAM results in the coming months.
The company anticipates completing the PMA submission shortly thereafter and is expediting manufacturing and commercial investments to replicate its European success in the U.S. This marks a pivotal moment in Nyxoah’s trajectory, underlining its commitment to innovation and growth.
