Bullish indicating open at $55-$60, IPO prices at $37
Investing.com -- Nyxoah SA (BR:NYXH) (NASDAQ:NYXH) stock jumped 9.4% following FDA approval of its Genio system for treating moderate to severe obstructive sleep apnea (OSA).
The Belgian medical technology company received marketing approval for its innovative hypoglossal nerve stimulation (HGNS) device for patients with an Apnea-Hypopnea Index between 15 and 65. The Genio system features bilateral stimulation with a leadless design and is compatible with full-body 1.5T and 3T MRI scans.
Nyxoah’s approval was supported by data from its DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate and a median AHI reduction of 70.8%. Notably, the system showed efficacy regardless of sleeping position, with a 66.6% median AHI reduction in the challenging supine position.
"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA," said Olivier Taelman, Nyxoah’s Chief Executive Officer. The company has already built a U.S. commercial organization and trained 75 physicians on the technology in anticipation of the launch.
Cantor Fitzgerald analyst Ross Osborn reiterated an Overweight rating and $14.00 price target on Nyxoah SA (NASDAQ:NYXH). The analyst commented, "Recall, NYXH has built out a full U.S. commercial organization in anticipation of FDA approval, and has 75 physicians already trained on the Genio technology in the U.S. Importantly, the Genio System is not contra-indicated for patients with Complete Concentric Collapse ( CCC (WA:CCCP)). Accordingly, with a U.S. launch on the horizon and NYXH having a differentiated hypoglossal nerve stimulation (HGNS) offering in a current one-player market, addressing an annual $10 billion U.S. market opportunity, we reiterate our OW rating."
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.