BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026. Ms. Smith Weber will oversee finance, accounting, and investor relations; and will serve as a key strategic partner to the Company’s executive leaders ...

Fractyl Health, Inc. (NASDAQ:GUTS) is one of the 10 Best New Penny Stocks to Invest In. On December 19, Canaccord Genuity reiterated its Buy rating on Fractyl Health, Inc. (NASDAQ:GUTS) with a price target of $8. This comes after a series of virtual meetings with the company’s leadership, including Co-founder and Chief Executive Officer, Dr. Harith Rajagopalan, along with Head of Investor Relations and Corporate Development, Brian Luque. During the meetings, many key areas of the business were discussed, ...

Core Insights - Fractyl Health, Inc. is focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases rather than just managing symptoms [2][3] - The company will participate in the 8th Annual Evercore Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders [1][2] Company Overview - Fractyl Health is based in Burlington, Massachusetts, and specializes in metabolic therapeutics [2] - The company has developed a significant intellectual property portfolio, including 33 granted U.S. patents and approximately 45 pending U.S. applications, along with various foreign patents [2] Industry Context - Obesity and T2D are increasingly recognized as major health challenges in the 21st century, contributing to rising morbidity and mortality rates [2] - The company aims to shift the treatment paradigm from chronic management to durable, disease-modifying therapies that target the organ-level causes of metabolic diseases [2]

Core Insights - Fractyl Health, Inc. is set to report its financial results for Q3 2025 on November 12, 2025, at 4:30 p.m. ET [1] - The company focuses on innovative treatments for obesity and type 2 diabetes (T2D), aiming to address the root causes of these metabolic diseases [3] Company Overview - Fractyl Health is dedicated to developing new therapeutic approaches for metabolic diseases, particularly obesity and T2D, which are significant contributors to morbidity and mortality in the 21st century [3] - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that target organ-level causes [3] - Fractyl Health has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with various foreign patents [3] - The company is headquartered in Burlington, Massachusetts [3]

Core Viewpoint - Fractyl Health, Inc. has announced a pricing of an underwritten offering of 60 million shares of common stock at $1.00 per share, aiming to raise approximately $60 million in gross proceeds before expenses [1][8]. Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D) [5][12]. - The company aims to shift the treatment paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of metabolic diseases [5][12]. - Fractyl has a strong intellectual property portfolio, including 33 granted U.S. patents and around 40 pending U.S. applications, along with numerous foreign patents [5][12]. Offering Details - The underwritten offering is expected to close on or about September 29, 2025, subject to customary closing conditions [1][8]. - BofA Securities and Evercore ISI are serving as joint book-running managers, while Ladenburg Thalmann is the lead manager for the offering [2][9]. - A shelf registration statement for the offering was filed with the SEC on March 3, 2025, and was declared effective on March 18, 2025 [3][10].

Core Insights - Fractyl Health, Inc. announced significant results from the REMAIN-1 Midpoint Cohort, indicating that the Revita procedure may be the first therapy to maintain weight loss after discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% total body weight compared to a 10% regain in sham-treated patients [2][3][10] Study Results - The REMAIN-1 Midpoint Cohort study involved 45 participants who had achieved at least 15% total body weight loss with tirzepatide, randomized to receive either Revita or a sham procedure [4][5] - At the 3-month mark, the study met its primary efficacy endpoint with a statistically significant p-value of 0.014, demonstrating the effectiveness of Revita in promoting further weight loss [8][10] - Safety and tolerability were excellent, with no serious adverse events related to Revita observed, and side effects were mild and transient [8] Future Outlook - The ongoing REMAIN-1 Midpoint Cohort is expected to provide 6-month data in Q1 2026, while the Pivotal Cohort aims to complete randomization in early 2026, with topline primary endpoint data and potential PMA filing anticipated in H2 2026 [11] - These milestones are crucial for establishing Revita as a potential first-in-class treatment for post-GLP-1 weight maintenance, opening a new therapeutic category in obesity care [11] Company Background - Fractyl Health focuses on innovative metabolic therapeutics targeting the root causes of obesity and type 2 diabetes, aiming to transform treatment from chronic management to durable disease-modifying therapies [13][15] - The company holds a robust intellectual property portfolio, including 33 granted U.S. patents and approximately 40 pending applications, positioning it well in the metabolic disease treatment landscape [13]

Company Overview - Fractyl Health, Inc. is a metabolic therapeutics company focused on innovative approaches to treat obesity and type 2 diabetes (T2D) [3] - The company aims to shift the treatment of metabolic diseases from chronic symptomatic management to durable disease-modifying therapies targeting organ-level root causes [3] - Fractyl has a strong intellectual property portfolio with 32 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign patents [3] Upcoming Events - The company will report its financial results for the second quarter of 2025 and provide business updates on August 12, 2025, at 4:30 p.m. ET [1] - Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO, will present at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 11:30 a.m. ET [2] - A live webcast of the conference call and presentation will be available on Fractyl Health's website, with an archived version for later access [2]

Core Insights - Fractyl Health, Inc. has strengthened its intellectual property portfolio with the issuance of two new U.S. patents, enhancing its leadership in metabolic innovation and duodenal resurfacing technologies [1][2][3] Intellectual Property Developments - The company has built a robust patent portfolio since 2011, now comprising 31 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign patents [2][5] - The newly issued patents focus on electrical energy ablation systems for treating tissue, specifically targeting duodenal mucosa with thermal and non-thermal energy applications [3][4] Product and Clinical Development - Fractyl's lead product candidate, Revita, aims to remodel the duodenal lining to reverse damage caused by high-fat and high-sugar diets, which are root causes of metabolic diseases [6][7] - Revita has received U.S. FDA Breakthrough Device designation for weight maintenance in patients who discontinue GLP-1-based drugs [6][7] - The company is preparing for three key data readouts from its pivotal study of Revita, with significant milestones expected in June 2025, Q3 2025, and the second half of 2026 [4][5]