On Monday, H.C. Wainwright maintained its Buy rating and $18.00 stock price target for Nyxoah SA (NASDAQ:NYXH), a company specializing in sleep-disordered breathing treatments. This follows the recent presentation of additional data from Nyxoah's DREAM pivotal study, which took place last Friday during the International Surgical Sleep Society (ISSS) 2024 Educational Update.
The DREAM study is a critical component in Nyxoah's strategy to gain marketing authorization for its Genio system in the United States. Genio, which has already received CE Mark approval in Europe, is a leadless, bilateral neurostimulation therapy designed to treat moderate-to-severe Obstructive Sleep Apnea (OSA). The therapy represents a novel approach in hypoglossal neurostimulation (HGNS) devices, aiming to provide relief for patients by stimulating both sides of the hypoglossal nerve.
The study targets adults with OSA who have either not responded to or refused continuous positive airway pressure (CPAP) therapy and do not have complete concentric collapse (CCC) of the soft palate during drug-induced sleep endoscopy (DISE). The objective is to evaluate both the safety and effectiveness of the Genio system.
H.C. Wainwright's reaffirmation of the Buy rating and price target is based on the positive data presented, which supports the potential market authorization of Genio in the U.S. The analyst's statement emphasizes the innovative nature of the Genio device and its significance in addressing OSA through bilateral stimulation, a feature that sets it apart in the market.
In other recent news, Nyxoah SA has reported significant progress in its DREAM U.S. pivotal study, with successful primary endpoints indicating a promising outlook for Obstructive Sleep Apnea (OSA) patients.
The company has completed its Pre-Market Approval (PMA) submission and anticipates FDA approval for its Genio system by late 2024 or early 2025. In financial developments, Nyxoah revealed a 29% increase in European sales and a successful capital raise of over EUR 85 million, extending its financial runway into mid-2026, despite an operating loss of EUR 13.3 million for Q2 2024.
Stifel has maintained a Buy rating on Nyxoah shares, targeting $18.00, following the presentation of additional data from the DREAM study. The firm highlighted the trial's demonstration of comparable efficacy in both supine and non-supine sleep positions as a significant positive development, although it noted an increase in device-related serious adverse events.
Nyxoah is making strategic moves in preparation for the U.S. launch of the Genio system, building its U.S. commercialization team and aiming to achieve profitability at around $250 million in U.S. sales. These recent developments reflect the company's strategic direction and optimism in the OSA treatment landscape.
InvestingPro Insights
Recent data from InvestingPro sheds additional light on Nyxoah SA's (NASDAQ:NYXH) financial position and market performance, offering valuable context to the company's pursuit of U.S. market authorization for its Genio system.
Despite the positive outlook from H.C. Wainwright, InvestingPro data reveals that Nyxoah is currently not profitable, with a P/E ratio of -6.65 over the last twelve months as of Q2 2024. This is not unexpected for a company in the medical device development stage, especially one pursuing innovative treatments like the Genio system.
On a more positive note, Nyxoah has demonstrated strong revenue growth, with a 57.79% increase over the last twelve months as of Q2 2024. This growth could be attributed to the CE Mark approval and subsequent sales of the Genio system in Europe.
InvestingPro Tips highlight that Nyxoah holds more cash than debt on its balance sheet, which could be crucial for funding ongoing research and development, including the DREAM study. However, the company is also quickly burning through cash, a common characteristic of companies in the medical technology sector pursuing regulatory approvals.
Investors should note that Nyxoah has shown significant returns recently, with a 21.25% price increase over the last month and a 39.17% increase over the last three months. This positive momentum may reflect market optimism about the company's progress with the Genio system and its potential for U.S. market entry.
For readers interested in a more comprehensive analysis, InvestingPro offers 11 additional tips for Nyxoah, providing a deeper understanding of the company's financial health and market position.
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