NATICK, Mass. - Allurion Technologies, Inc. (NYSE: ALUR), a biotechnology firm focused on obesity treatment, announced the topline results from its AUDACITY FDA pivotal trial, which evaluated the safety and efficacy of the Allurion Balloon, a non-surgical weight loss device. According to InvestingPro data, the company maintains impressive gross profit margins of 73%, though it currently faces significant cash burn challenges. The study revealed that over half of the participants treated with the Allurion Balloon achieved significant weight loss at 48 weeks.
The AUDACITY trial, which is the first FDA pivotal trial for an intragastric balloon to report outcomes beyond nine months, involved 550 subjects. They were randomized to receive either two cycles of the Allurion Balloon or a control group that underwent moderate intensity lifestyle therapy. The trial's co-primary endpoints were based on responder rates and the percentage of total body weight loss at 48 weeks.
Results showed that 58% of subjects with the Allurion Balloon lost more than 5% of their total body weight. However, the trial did not meet the comparative co-primary endpoint of a 3% superiority margin in weight loss over the control group, with a 3.77% mean difference noted instead.
Additionally, the trial reported a low rate of serious adverse events at 3.1%, marking it as the lowest in a pivotal FDA trial for a liquid-filled intragastric balloon.
Dr. Shelby Sullivan, Lead Investigator of the AUDACITY trial, expressed confidence in the Allurion Balloon's favorable benefit-risk profile for obesity treatment. Dr. Ram Chuttani, Chief Medical (TASE:PMCN) Officer of Allurion, also highlighted the balloon's positive impact on weight loss and safety record.
The company plans to submit the final module of the Pre-Market Approval (PMA) application to the FDA based on the AUDACITY trial results. With current revenue of $34.75 million and a market capitalization of $24.68 million, Allurion's stock appears undervalued according to InvestingPro's Fair Value analysis. Get access to the comprehensive Pro Research Report for deep-dive analysis of ALUR and 1,400+ other US stocks. Allurion's CEO, Dr. Shantanu Gaur, noted the trial's success and the potential of combining the Allurion Balloon with their AI-powered Virtual Care Suite, which has shown even greater weight loss in over 150,000 patients outside the United States.
Further data from the AUDACITY trial will be presented at upcoming medical meetings. The Allurion Gastric Balloon remains an investigational device in the U.S. This news is based on a press release statement.
In other recent news, Allurion Technologies announced a series of significant developments. The company recently expanded its board, appointing R. Jason Richey as a Class II director. This comes alongside a one-for-twenty-five reverse stock split aimed at elevating the market price of its common stock. Allurion's shareholders approved key proposals, including the re-election of three Class I directors and a reverse stock split. They also ratified the appointment of Deloitte & Touche LLP as the company's independent registered public accounting firm for the current fiscal year.
In the analyst arena, TD Cowen maintains a Buy rating for Allurion, recognizing the company's strategic plan to improve commercial performance and significantly cut operating costs. However, Chardan Capital Markets downgraded Allurion's stock from Buy to Neutral, citing a pattern of underwhelming business performance.
Allurion's third-quarter revenue was reported to be $5.4 million, leading the company to revise its full-year 2024 revenue guidance to fall between $30 million and $35 million. The company also plans to cut its operating expenses by half and reduce its workforce by 50% by 2025. These are recent developments, and investors are eagerly awaiting the end-of-year Audacity study results, which could influence the company's future direction.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.