Stifel has reaffirmed its Buy rating and a price target of $18.00 on shares of Nyxoah SA (NASDAQ: NYXH).
The reiteration follows the presentation of additional data from Nyxoah's U.S. DREAM pivotal trial at the 2024 ISSS conference on Friday.
The company had previously announced preliminary topline data from the DREAM study earlier this year, which indicated successful primary endpoints.
The progress led to the submission of the final module of its Pre-Market Approval (PMA) to the FDA in July, with the company anticipating FDA approval for its Genio device by the end of 2024.
The recent conference shed light on the DREAM trial's patient demographics, study protocols, safety outcomes, and primary, secondary, and exploratory endpoints, including data on positional sleep efficacy.
Stifel highlighted the trial's demonstration of comparable efficacy in both supine and non-supine sleep positions as a significant positive development. However, the firm also noted an increase in device-related serious adverse events (SAEs) as a major concern.
The Genio system by Nyxoah is designed to treat obstructive sleep apnea (OSA), a condition characterized by the cessation of breathing during sleep due to throat muscles relaxing and blocking the airway. The positive trial results and the potential FDA approval represent crucial milestones for the company as it seeks to enter the U.S. market with its innovative therapy.
The DREAM trial's success is a step forward for Nyxoah in its quest to provide an effective treatment option for OSA sufferers. With the FDA's decision expected by the end of the year, the company is poised to potentially bring a new solution to a market with a significant patient population seeking alternatives to current OSA treatments.
In other recent news, medical technology firm Nyxoah SA reported its Q2 2024 financial results, revealing a 29% increase in European sales and a successful capital raise of over EUR 85 million.
The company's DREAM U.S. pivotal study met its primary endpoints, showing promising results for Obstructive Sleep Apnea (OSA) patients. Nyxoah also completed its PMA submission, anticipating FDA approval for its Genio system by late 2024 or early 2025.
Despite an operating loss of EUR 13.3 million for Q2 2024, the company's strong capital raise extends its financial runway into mid-2026. Nyxoah is building its U.S. commercialization team and preparing for the U.S. launch of the Genio system.
The company aims to achieve profitability at around $250 million in U.S. sales.
InvestingPro Insights
Recent data from InvestingPro provides additional context to Nyxoah's (NASDAQ:NYXH) financial position and market performance as it approaches potential FDA approval for its Genio device. The company's market capitalization stands at $320.96 million, reflecting investor interest in its innovative OSA treatment technology.
InvestingPro Tips highlight that Nyxoah holds more cash than debt on its balance sheet, which could be crucial for supporting the company through the FDA approval process and potential market entry. However, the company is also quickly burning through cash, a common characteristic for biotech firms in the pre-approval stage.
Nyxoah's revenue growth of 57.79% over the last twelve months as of Q2 2024 indicates strong commercial traction, possibly in its existing markets. This growth aligns with the positive outlook suggested by the DREAM trial results. However, with a high revenue valuation multiple, investors are pricing in significant future growth expectations.
The stock has shown strong returns over the last week (13.72%), month (21.25%), and three months (39.17%), potentially reflecting market optimism about the DREAM trial data and upcoming FDA decision. Investors should note that analysts do not anticipate profitability this year, which is not unusual for companies at this stage of development in the medical device sector.
For readers interested in a deeper analysis, InvestingPro offers 11 additional tips for Nyxoah, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.