StockNews.AI
ALUR
StockNews.AI
43 days

Allurion Announces Submission of PMA to FDA and Additional Analyses From Pivotal AUDACITY Study That Meet Both Endpoints

1. Allurion submitted the fourth PMA module to the FDA. 2. AUDACITY Study met co-primary endpoints for weight loss. 3. Adjustments in data improved weight loss results in analyses. 4. The Allurion Balloon shows potential exceeding pre-specified margins. 5. CEO expresses optimism for FDA approval timeline.

9m saved
Insight
Article

FAQ

Why Bullish?

The successful submission of the PMA and strong study results indicate increased likelihood of FDA approval, positively impacting stock price similar to prior successful filings within the healthcare sector.

How important is it?

The news directly relates to ALUR's pathway to market approval, significantly influencing investor sentiment and valuation.

Why Short Term?

FDA review timelines are usually within 6-12 months, which corresponds to a short-term impact on ALUR’s stock price.

Related Companies

MEDPNXGNTDOC
-Fourth and final module of the PMA submitted in JuneSupportive analyses included in final module of the PMA meet both of the pre-specified co-primary endpoints in the AUDACITY Study NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced submission of the fourth and final module of the Pre-Market Approval (PMA) application to the Food & Drug Administration (FDA) and additional, supportive analyses from the AUDACITY Study that meet both of the pre-specified co-primary endpoints. Topline results announced previously showed that the AUDACITY Study met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects. Additional analyses submitted in the PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p = .0142). At 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p = .0006). “We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “We believe that these analyses are more suitable for the trends observed in both groups in the AUDACITY Study and further strengthen our positive topline data. With the PMA now submitted, we are looking forward to working with the FDA toward an approval.” The AUDACITY Study is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. 550 subjects were randomized 1:1 to either two cycles of the Allurion Balloon1 or a control group that received moderate intensity lifestyle therapy. Subjects in the treatment group received their first Allurion Balloon at Week 0, which passes at approximately Week 16, and a second Allurion Balloon at Week 24, which passes at approximately Week 40. Co-primary endpoints based on Allurion Balloon subject responders and a comparison of percent total body weight loss between groups were measured at Week 48, approximately eight weeks after the second Allurion Balloon passes at Week 40. About Allurion Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world’s first and only swallowable, Procedureless™ gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan. The Allurion Gastric Balloon is an investigational device in the United States. For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com. Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world. Forward-Looking Statements This press release contains forward-looking statements that reflect Allurion’s beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this release, these statements involve risks and uncertainties that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: the timing of the FDA’s review of the Company’s PMA application for the Allurion Balloon, the approval by the FDA of the Company’s PMA application for the Allurion Balloon; the FDA’s willingness to consider the Company’s use of additional, supportive analyses regarding imputation methods with respect to achievement of the second co-primary endpoint; the uniqueness of Allurion’s product and service offerings, including the Allurion Program; and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to management. Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program, including the Allurion Balloon; the timing of, and results from, Allurion’s clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Balloon; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; a changing regulatory landscape in the highly competitive industry in which Allurion competes; the impact of the imposition of current and potential tariffs and trade negotiations, and those factors discussed under the heading “Risk Factors” in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025, and updated from time to time by its other filings with the SEC, and its Quarterly Report on Form 10-Q filed with the SEC on May 15, 2025. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law. More News From Allurion Technologies, Inc.

Related News