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Investing.com -- Allurion Technologies Inc. (NYSE:ALUR) stock surged 10.9% in Tuesday’s premarket trading after the weight loss technology company announced significant progress in its FDA approval process and a debt exchange transaction that would make the company debt-free.
The metabolic health company reported passing critical milestones in the FDA Pre-Market Approval (PMA) process for its Allurion Smart Capsule. In recent months, the company successfully completed FDA pre-approval and Bioresearch Monitoring inspections with zero findings, and held its Day-100 Meeting with the FDA, where no additional human clinical data was requested.
"Passing these FDA inspections with no findings and completing the Day-100 Meeting are major milestones for Allurion, and we believe we are now entering the final stages of the review process," said Dr. Shantanu Gaur, Founder and Chief Executive Officer of the Company.
Alongside the regulatory progress, Allurion announced a transaction to exchange all outstanding debt for shares of newly created Series B Convertible Preferred Stock. The preferred stock will be convertible at an initial price of $3.37 per share and will accrue dividends at a rate of 8.25% per annum. The transaction is subject to stockholder approval and other closing conditions.
The company also secured $5 million through a private placement financing with participation from new and existing stockholders and a strategic partner specializing in obesity treatment. The financing included the sale of nearly 3 million shares of common stock and warrants at $1.67 per share.
Allurion submitted the final module of its PMA application in June 2025, with the FDA completing its Acceptance and Filing Reviews process in July before entering the Substantive Review phase. The company is positioning itself financially for a potential U.S. launch of its weight loss technology, pending FDA approval.
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