On Wednesday, Stifel, a financial services firm, increased its price target for Nyxoah SA (NASDAQ:NYXH) to $27, up from the previous $20, while maintaining a Buy rating on the stock. The revision follows Nyxoah's announcement of positive top line data from its U.S. DREAM pivotal trial after the market closed. The data revealed that the trial met its primary endpoints, which include the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI), key measures in sleep apnea treatment efficacy.
This successful outcome enables Nyxoah to proceed with the submission of its fourth and final Premarket Approval (PMA) module to the U.S. Food and Drug Administration (FDA). The company anticipates receiving FDA approval for its product in late 2024 or early 2025.
The DREAM trial's findings are noteworthy, with a median AHI reduction of 71%, compared to a 68% reduction in the STAR pivotal trial of Inspire Medical Systems (NYSE:INSP), a competitor in the sleep apnea treatment market. Additionally, the patient rate for serious adverse events (SAEs) in the DREAM trial was 9%, significantly lower than the 21% reported in the STAR trial, although the rates of device-related SAEs were comparable between the two.
Furthermore, the DREAM trial demonstrated consistent AHI improvement across different sleeping positions, which is a positive indicator for Nyxoah's commercial prospects. However, it's worth noting that the AHI and ODI responder rates for Nyxoah's Genio system, while statistically significant, did not surpass the outcomes observed in the STAR trial. Additionally, the Genio system had a higher explant rate, despite recording fewer SAEs overall.
More details on the DREAM trial will be released at the ISSS conference in September.
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