Fractyl Health, Inc. received notification from Nasdaq on September 10, 2026, that its common stock is subject to delisting because the minimum bid price remained below $1.00 for 30 consecutive business days and failed to regain compliance within the 180-day grace period. The company intends to request a hearing before the Nasdaq Hearings Panel, which will stay any suspension or delisting pending the outcome. To address the deficiency, Fractyl filed a proxy statement on August 24, 2026, seeking shareholder approval for a reverse stock split with a ratio ranging from 1-for-5 to 1-for-15. The company operates in the healthcare sector, specifically developing therapies for metabolic diseases.

Fractyl Health reported second quarter 2026 financial results and provided clinical updates. The company posted a net loss of $25.5 million, compared to $27.9 million in the prior year period, driven by reduced R&D expenses of $13.8 million against $21.2 million previously. Cash and cash equivalents stood at approximately $47.1 million as of June 30, 2026, with management projecting a cash runway into early 2027. Clinically, one-year data from the REMAIN-1 Midpoint Cohort showed Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% for sham controls. Topline six-month randomized data from the REMain-1 Pivotal Cohort is expected in early Q4 2026, potentially paving the way for an FDA De Novo submission later that quarter. Fractyl Health operates in the biotechnology and medical device industry, developing procedural therapies and gene treatments for obesity and type 2 diabetes.

Fractyl Health, Inc. reported one-year results from its REMAIN-1 Midpoint Cohort study, showing the Revita DMR System can reduce weight regain after GLP-1 discontinuation. In the full mITT population (N=45), Revita reduced weight regain by approximately 40% compared to sham (7.8% vs 13.0% body weight regain). Participants with complete duodenal ablation (>14 cm) maintained 81% of GLP-1-induced weight loss at one year. Fractyl Health, Inc. is a medical device company focused on metabolic health and weight management solutions.

Fractyl Health announced positive one-year results from its REVEAL-1 Cohort, reporting that patients who underwent the Revita procedure maintained approximately 78% of their prior GLP-1-induced weight loss. Additionally, 33% of participants continued to lose weight at the one-year mark, and 100% of patients maintained at least 5% of their drug-induced weight loss.