Chardan Capital Markets raised its rating on Allurion Technologies (NYSE:ALUR) from Neutral to Buy and set a $3.00 price target following the U.S. Food and Drug Administration approval of the company Allurion Gastric Balloon System, which incorporates the Allurion Smart Capsule. The upgrade was announced Monday, after recent clinical data and the FDA decision provided the basis for the change in stance.
The stock has reacted strongly to the news, climbing 62% over the prior week to trade at $1.75, according to InvestingPro data. Despite the jump, the share price remains materially under the analyst target.
The FDA clearance was supported by findings from the U.S. pivotal study AUDACITY. In that trial, 58% of subjects using the Allurion Balloon lost more than 5% of their total body weight at 48 weeks. A later analysis reported a mean difference in percentage total body weight lost between the treatment and control groups of 4.34% at 48 weeks, which exceeded the pre-specified super-superiority margin of 3.00%. At 40 weeks, the mean difference reached 4.90%, surpassing the 3.75% super-superiority margin established for that time point.
Operationally, Allurion plans a phased commercial rollout in the United States. The company will initially target bariatric surgeons and gastroenterologists using a limited direct sales force. The planned launch strategy emphasizes offering the Allurion Program in combination with GLP-1 medications, with an explicit focus on three patient groups: those who have stopped GLP-1 therapy, patients seeking non-surgical alternatives to bariatric procedures, and individuals preferring lower doses of GLP-1 treatments.
Chardan anticipates minimal U.S. revenue in 2026 as Allurion works to establish clinical and practitioner credibility. The firm also noted that the company is exploring distribution through independent sales representatives as part of its commercialization strategy.
Financially, Allurion is a small-cap company with a market capitalization of $21.49 million. The firm reported a gross profit margin of 61% despite currently operating at a loss. InvestingPro provides additional investor guidance, offering 18 supplementary tips for ALUR that include commentary on cash burn and debt levels.
Separately, Allurion has pursued partnerships tied to its device. The company announced a collaboration with Bionut in Argentina to make discounted Mounjaro (tirzepatide) available alongside the Allurion Smart Capsule. The intent of that arrangement is to enhance weight-loss results using lower doses of GLP-1 medications.
Clinical data shared by Allurion indicated that patients who used the Smart Capsule balloon in combination with low-dose tirzepatide achieved an average 23% total body weight loss over 12 months. In the same cohort of 76 patients, the combination therapy was associated with a 14% increase in lean body mass. The reported tirzepatide doses in that analysis were lower than typical standard treatment levels.
Context for investors
The upgrade and FDA approval create a new commercial pathway for Allurion in the U.S. market, but the company faces a multi-step build-out to produce meaningful revenue domestically. Observers should weigh recent clinical readouts and the planned targeted launch strategy against the company current financial profile and limited sales infrastructure.