Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced completion of participant r ...

Core Viewpoint - Fractyl Health, Inc. (GUTS) has experienced a significant decline of 77.6% in its stock price over the past four weeks, but it is now in oversold territory, suggesting a potential for a turnaround as analysts expect better earnings than previously predicted [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2]. - GUTS has an RSI reading of 24.79, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound [5]. - The RSI helps investors identify potential entry points for stocks that have fallen below their fair value due to excessive selling [3]. Group 2: Fundamental Indicators - Analysts covering GUTS have raised their earnings estimates for the current year, resulting in a 1.8% increase in the consensus EPS estimate over the last 30 days, which often correlates with price appreciation [7]. - GUTS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a near-term turnaround [8].

Core Insights - Fractyl Health (GUTS) is focused on developing endoscopic procedures aimed at managing metabolic diseases, specifically obesity and diabetes [1] - The company's lead candidate, Revita, is currently undergoing a registrational phase 3 trial, with topline results anticipated in the second half of 2026 [1] Company Overview - Fractyl Health is engaged in the clinical research of innovative treatments for metabolic disorders [1] - The investment strategy involves focusing on clinical-stage biotech stocks, emphasizing both long-term investment ideas and event-driven trading [1] Clinical Development - Revita is the primary product in development, which is expected to play a significant role in the management of metabolic diseases [1] - The ongoing phase 3 trial is a critical step in the regulatory process, with results expected to influence future investment and market strategies [1]

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Core Viewpoint - Fractyl Health, Inc. is currently under investigation on behalf of investors, indicating potential legal concerns that may affect the company's operations and investor confidence [1] Company Summary - The investigation is being conducted by DJS Law Group, which suggests that there may be significant issues regarding the company's practices or disclosures that warrant scrutiny [1]

Core Viewpoint - GUTS is currently under scrutiny following Morgan Stanley's announcement of a price target of $2, indicating a potential increase of approximately 245% from its current trading price of $0.58 [1][5]. Price Performance - The stock is currently priced at $0.58, reflecting a significant decrease of 68.04% from previous levels, which translates to a drop of $1.24 [2][5]. - Over the past year, GUTS has experienced a high of $3.03 and a low of $0.56, showcasing its volatility and potential for significant price movements [3][5]. Market Activity - The market capitalization of GUTS is approximately $42.23 million, indicating the company's size and market presence [3]. - The trading volume for GUTS is 87.51 million shares, suggesting active investor interest and reflecting the market's response to recent developments, including Morgan Stanley's price target announcement [4][5].

Core Viewpoint - Fractyl Health Inc. experienced a significant decline in stock price following a potential shift in its regulatory strategy for its lead product, Revita, which is designed to address chronic metabolic diseases [1][8]. Product Overview - Revita is a minimally invasive endoscopic procedure aimed at remodeling the duodenal lining to restore nutrient sensing and signaling disrupted by chronic metabolic disease [2]. - The product has received FDA Breakthrough Device designation for weight maintenance in patients who stop GLP-1 therapies [2]. Regulatory Strategy - The company is seeking FDA feedback on reclassifying Revita under the De Novo pathway instead of the Premarket Approval (PMA) process, which may allow for a more efficient regulatory review [3]. - Feedback from the FDA regarding the De Novo pathway is anticipated in the second quarter of 2026 [4]. Clinical Trial Results - In a six-month randomized study, Revita-treated patients showed a 4.5% weight regain compared to 7.5% in the sham group, indicating a significant reduction in expected weight regain after GLP-1 therapy discontinuation [5]. - An exploratory analysis indicated that patients with above-median weight loss during GLP-1 run-in experienced a 4.2% weight regain versus 13.3% in the sham group, reflecting a 70% relative reduction in post-GLP-1 weight regain [6]. Metabolic Improvements - Revita-treated patients exhibited improvements in cardiometabolic lipid parameters, including a 15.5 mg/dL increase in HDL cholesterol and a reduction in triglyceride-to-HDL ratio, suggesting enhanced metabolic regulation [7]. - Patient-reported outcomes indicated a significant reduction in sweet-food cravings in the Revita group compared to the sham group [7]. Safety Profile - The safety and tolerability of Revita remained favorable over six months, with no serious adverse events related to the device or procedure, and no study discontinuations due to adverse events [8].

Core Viewpoint - Fractyl Health is conducting a conference call to discuss the 6-month REMAIN-1 Midpoint Cohort results, with a focus on the company's developments and future outlook [1][2]. Group 1: Company Overview - The conference is led by Lara Smith-Weber, the Chief Financial Officer, and features Dr. Harith Rajagopalan, the Co-Founder and CEO of Fractyl Health [1][2]. - A press release detailing the topics for discussion has been issued and is available on the company's website under the Investors tab [2]. Group 2: Forward-Looking Statements - The company will make forward-looking statements during the call, which involve risks and uncertainties that could lead to actual results differing from these statements [3]. - A comprehensive list of risk factors is provided in the company's SEC filings, including the quarterly report Form 10-Q filed on November 12, 2025 [3].

Fractyl Health (NasdaqGM:GUTS) Update Summary Company Overview - **Company**: Fractyl Health - **Industry**: Obesity treatment and metabolic disease management - **Product**: Revita, a one-time outpatient endoscopic procedure aimed at post GLP-1 weight maintenance Key Points from the Call Clinical Data and Study Results - The REMAIN-1 midpoint cohort pilot study presented data showing that Revita maintained weight six months after discontinuation of GLP-1s, indicating potential for a new therapeutic category in obesity [4][5] - Revita-treated patients experienced a 4.5% weight regain compared to 7.5% in the sham group, representing a significant reduction in post-GLP-1 rebound [11] - Patients with greater GLP-1-associated weight loss saw a 70% reduction in weight regain with Revita versus sham, with a p-value of 0.004 [14] - The study included 45 adults with obesity, achieving at least 15% total body weight loss on tirzepatide before randomization [9] - Safety profile remained stable with no new adverse events reported between the three-month and six-month follow-ups [17] Regulatory and Commercialization Path - Fractyl Health is in discussions with the FDA regarding reclassifying Revita under the De Novo pathway, which could streamline the regulatory review process [6][19] - The company anticipates FDA feedback on this request in Q2 2026 [19] - Plans for commercialization include leveraging FDA breakthrough device designation and CMS transitional pass-through mechanisms [20] - The potential market includes 2,000-4,000 endoscopy suites in the U.S., with an estimated capacity for 2-4 million procedures annually [22] Future Catalysts and Milestones - Upcoming milestones include completing randomization in the pivotal cohort by February 2026 and top-line pivotal data expected in the second half of 2026 [18][23] - The company is preparing for a potential FDA submission and CPT code filing, aiming for simultaneous implementation with FDA approval [20] Insights on Efficacy and Market Position - Revita is positioned as a potential backbone therapy in obesity, particularly for patients at high risk of weight regain after GLP-1 therapy [8] - The data suggests that Revita may help maintain a lower body weight set point, supported by improvements in cardiometabolic parameters and reduced food cravings [16][17] - The pivotal study is designed to mirror the REMAIN-1 cohort, ensuring consistency in inclusion and exclusion criteria [18] Additional Considerations - The study's design intentionally focused on patients with significant weight loss on GLP-1 therapy, who are at the highest risk for weight regain [13] - The company remains confident in the ongoing pivotal study's power to demonstrate efficacy, with a sample size of 315 patients [26] Conclusion Fractyl Health is advancing its Revita product through promising clinical data and strategic regulatory discussions, positioning itself for a significant impact in the obesity treatment market. The upcoming year is expected to be catalyst-rich, with critical data and regulatory milestones on the horizon [67]

Core Insights - Fractyl Health, Inc. announced positive six-month results from the REMAIN-1 Midpoint Cohort study, indicating that Revita® effectively supports weight maintenance after GLP-1 drug discontinuation [2][3] - Revita-treated patients showed a significant reduction in weight regain compared to the sham group, with a 70% relative reduction in post-GLP-1 weight regain for those with above median GLP-1-associated weight loss [1][8] - The company is preparing for a potential FDA filing in H2 2026 and has requested feedback on reclassifying Revita under the De Novo pathway [1][10] Study Results - The REMAIN-1 Midpoint Cohort demonstrated a 4.5% weight regain in Revita-treated patients versus 7.5% in the sham group at six months, with a p-value of 0.07 [4][8] - An exploratory analysis revealed that Revita-treated participants experienced 4.2% weight regain compared to 13.3% in the sham group, with a statistically significant p-value of 0.004 [8] - Improvements in cardiometabolic parameters were noted, including a 15.5 mg/dL increase in HDL cholesterol and a reduction in the triglyceride-to-HDL ratio [8] Safety and Tolerability - Revita demonstrated excellent safety and tolerability, with no serious adverse events related to the device or procedure reported through six months [15] - No new adverse events were observed between the 3- and 6-month follow-up periods [15] Regulatory Strategy - The company is engaging with the FDA regarding the potential for using the De Novo pathway, which may streamline the regulatory review process for Revita [10] - Feedback from the FDA is anticipated in Q2 2026, which will inform the regulatory strategy moving forward [10] Future Milestones - Fractyl Health is on track for several key clinical and regulatory milestones in 2026, including the completion of randomizations in the REMAIN-1 Pivotal Cohort and the release of one-year data from the REVEAL-1 Cohort [16] - The company plans to host an investor call and webcast to discuss these developments [11]