GUTS stock plunges as Fractyl Health faces securities lawsuit. ELLIS HOBBS - UPDATED OCT. 17, 2026, 10:06 AM ET Fractyl Health, Inc. faces heightened pressure after negative trial data, with stocks having been trading down by -68.51 percent. What traders need to know. * A securities class action has been filed against Fractyl Health (GUTS) alleging the company overstated the efficacy and prospects of its Revita DMR System and misled investors about REMAIN-1 Midpoint Cohort data between 2025/01/13 and 2026/01/29. * When more complete six-month REMAIN-1 data revealed weaker-than-touted weight-maintenance results and issues at an outlier trial site, Fractyl Health's stock price collapsed by roughly 68-75% over one to two days and was subsequently downgraded by Morgan Stanley with reduced peak-sales expectations. * Plaintiffs allege Fractyl used allegedly inflated interim Revita trial data and failed to disclose site-level operational problems while conducting two equity offerings in August and September 2025 that raised about $76.7M. * The lawsuit, which has an 2026/10/20 lead-plaintiff deadline, focuses on alleged misstatements around trial design, data integrity, and risk disclosure, creating heightened legal, regulatory, execution, and financing risk for the company. Weekly Update Oct 12 - Oct 16, 2026: On Saturday, October 17, 2026 Fractyl Health, Inc. stock [NASDAQ: GUTS] is trending down by -68.51%! Discover the key drivers behind this movement as well as its expert analysis in the detailed breakdown below. Healthcare industry expert: Analyst sentiment - negative Fractyl Health (GUTS) is a single-asset, pre-revenue obesity/diabetes platform with biotech-typical negative profitability and extreme balance-sheet fragility. Q2 2026 EBITDA was -$25.3M and net income -$25.5M, implying an annualized burn of roughly $90-$110M. Free cash flow was -$15.9M for the quarter, with cash of $47.1M and working capital of $33.9M, giving barely 4-6 quarters of runway. Negative equity (-$1.7M) and ROA below -70% underscore weak fundamentals and high financing dependence. Technically, GUTS has transitioned from a tight $4.00-4.50 consolidation to a violent breakdown, with the latest weekly bar collapsing from a $4.12 close to $1.31 on heavy volume, confirming a dominant bearish trend and capitulation-style selling. Intraday 5-minute candles show repeated failed bounces above $1.50, with supply hitting every spike. The key actionable level is $1.50: below it, rallies are short-sale opportunities; only sustained closes above $1.80 would signal a tradable short-covering reversal. The litigation over alleged misrepresentation of Revita REMAIN-1 data, coupled with a ~70-75% price collapse and major-bank downgrades, creates a severe legal and reputational overhang. Versus broader healthcare and biotech benchmarks, GUTS now trades as a distressed, binary-outcome trial asset with subscale cash and constrained access to equity markets. Base case is continued value erosion absent unequivocally positive new data. I see fair value skewed lower, with resistance at $1.80 and $2.50, support fragile near $1.00. Quick financial overview. Fractyl Health, Inc. (GUTS) is trading under heavy pressure after the REMAIN-1 Midpoint Cohort data reset expectations for its Revita DMR System. Weekly prices show the stock trading around $4.41-$4.16 early in the data window, then collapsing to a $1.55 open and $1.31 close by the latest print. That pattern lines up with the reported 68-75% slide over one to two days once six-month results and an outlier trial site were disclosed. Intraday data reinforce the volatility story. A 5-minute candle with a $2.30 high and $1.53 low, closing near $1.55, points to aggressive selling into any bounce and wide intraday ranges. For short-term traders, that means spreads, slippage, and headline risk matter more than usual. Failed attempts to hold above the low $2s suggest that prior support zones have turned into resistance until sentiment improves. Fundamentally, GUTS is still a pre-profit, cash-burning biotech. The latest quarterly report shows a net loss of about $25.5M and free cash flow around -$15.9M, but with $51.4M of cash at period-end and working capital near $33.9M. Key ratios show a very weak return on assets and a negative book value per share of roughly -$0.13, which is why the price-to-book metric screens as sharply negative. On the positive side, a current ratio above 3 implies near-term liquidity is adequate, but ongoing legal and trial risks raise questions about how Fractyl Health, Inc. will fund itself once this cash runway shortens. Conclusion. This is stock news, not investment advice. Timothy Sykes News delivers real-time stock market news focused on key catalysts driving short-term price movements. Its content is tailored for active traders and investors seeking to capitalize on rapid price fluctuations, particularly in volatile sectors like penny stocks. Readers come to Millionaire Media, LLC. for detailed coverage on earnings reports, mergers, FDA approvals, new contracts, and unusual trading volumes that can trigger significant short-term price action. Some users utilize its news to explain sudden stock movements, while others rely on it for diligent research into potential investment opportunities. Dive deeper into the world of trading with Timothy Sykes, renowned for his expertise in penny stocks. Explore his top picks and discover the strategies that have propelled him to success with these articles: Once you've got some stocks on watch, elevate your trading game with StocksToTrade the ultimate platform for traders. With specialized tools for swing and day trading, StocksToTrade will guide you through the market's twists and turns. Dig into StocksToTrade's watchlists here: Trump's sons. Golf courses. Combat drones. Explain that one. Trump's sons. Golf courses. Combat drones. Explain that one. 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Fractyl reports less weight regain with Revita after tirzepatide in six-month trial results. The company reports 5.1% average weight regain versus 8.2% with sham. One-year results and fuller analysis details are still pending; Revita remains investigational in the U.S. Brief by Alex Brecher, founder of BariatricPal Published October 16, 2026 Evidence: Company-reported trial results Industry disclosure: Fractyl Health is developing Revita and issued the trial announcement. The results have not been independently verified by BariatricPal. Evidence strength Company-reported, randomized, double-blind, sham-controlled pivotal trial; 308-person cohort, six-month comparison with displayed samples of 176 and 74. Full manuscript and complete analysis details were not provided in the announcement. Who this applies to Adults with obesity, BMI 30 to 45, without type 2 diabetes, who achieved at least 15% weight loss on tirzepatide before discontinuation. These results do not establish the same benefit for other medicines or populations. In this brief Fractyl Health says its experimental Revita procedure reduced weight regain after tirzepatide was stopped in the six-month comparison of its REMAIN-1 pivotal trial. The company reported adjusted average regain of 5.1% of body weight with Revita versus 8.2% with a sham procedure, a difference of 3.1 percentage points. Both groups regained weight on average. The October 16 company announcement reports that the study met its prespecified six-month co-primary endpoint, with a p-value of 0.0023. That is an encouraging comparison for a procedure being developed for weight maintenance after medication, but it is a preliminary company report. The study's other co-primary endpoint is measured at one year and has not yet been reported. Revita remains investigational in the United States. Fractyl's October 16 announcement is the source for the results and development plans below. REMAIN-1's pivotal cohort includes 308 adults at more than 30 U.S. sites. According to Fractyl, participants had obesity, with a starting body mass index of 30 to 45, did not have type 2 diabetes and had not previously received GLP-1 therapy. They first received tirzepatide and achieved at least 15% total body weight loss. After stopping the medicine, they were randomly assigned in a two-to-one ratio to one Revita treatment or a sham endoscopic procedure. Revita is designed to remodel the lining of the duodenum, the first part of the small intestine. The sham comparison and double-blind design, in which treatment assignment is concealed, help investigators assess whether the procedure changes regain beyond what occurs in the comparison group. This is a selected population that had already achieved substantial weight loss with tirzepatide. It does not establish the same result in people with diabetes, people who lose less weight or people discontinuing a different medicine. Fractyl also describes the results as retention of approximately 80% of the medication-induced weight loss with Revita versus 67% with sham. Those percentages describe the share of earlier weight loss retained. They do not mean participants lost another 80% of their body weight or that 80% avoided all regain. The adjusted regain figures are group averages, not a prediction for an individual. The announcement leaves important analysis details unresolved. The release labels the modified intention-to-treat population as 308 participants, while listing sample sizes of 176 for Revita and 74 for sham beside the six-month result. Those two numbers total 250. The announcement does not explain how those displayed samples relate to the stated modified intention-to-treat population of 308. It does not provide confidence intervals for the main comparison. A full statistical report is needed to assess those details. Fractyl highlights larger differences among participants who received longer lengths of duodenal treatment. Those analyses were performed after the fact, rather than being the main prespecified comparison, and should not be treated as proof that a particular treatment length will produce a particular benefit. The release says formal statistical testing of key secondary endpoints follows assessment of the one-year co-primary endpoint. For safety, Fractyl reports no device- or procedure-related serious adverse events, no deaths and no unanticipated adverse device effects through its September 24 data cutoff. It says related adverse events were predominantly mild and occurred around the procedure. This is interim reporting from an ongoing trial and does not establish that the procedure is risk free. This brief is based on the full company announcement, not a peer-reviewed full manuscript or a complete safety dataset. One-year results and an FDA submission are still ahead. Fractyl expects one-year results in the first quarter of 2027. That second co-primary endpoint asks what proportion of Revita participants maintain at least 5% total body weight loss relative to their weight before tirzepatide, against a prespecified performance goal greater than 50%. It is a different question from the six-month comparison of regain between groups. The company plans a De Novo marketing application to the FDA in late 2026. Its potential authorization and launch dates are company projections, not approvals or commitments from the regulator. For readers, the current development is evidence of less average regain over the reported follow-up in a selected trial population. It does not establish permanent maintenance, replacement of medication for everyone or current U.S. treatment availability. The brief, in short. * What happened - Fractyl reported that its Revita procedure reduced average weight regain compared with a sham procedure after tirzepatide discontinuation in REMAIN-1. * What it means - The reported difference is 3.1 percentage points of body weight. Both groups regained weight on average, and retention of earlier weight loss is not the same as avoiding all regain. * Limits - Company-reported topline results, not a peer-reviewed full manuscript. The displayed six-month samples total 250 within a stated 308-person cohort, without enough explanation to reconcile them. Confidence intervals and one-year results are not provided. U.S. use remains investigational. * What to watch next - Fractyl plans an FDA De Novo submission in late 2026 and expects one-year REMAIN-1 results in the first quarter of 2027. Questions worth asking your surgeon or prescriber. * How do the participants in REMAIN-1 compare with my situation? * What will the one-year results add to the six-month findings? * What remains unknown about the procedure's risks and durability? General information, not medical advice. Sources and documents. Educational information only. This brief is not medical advice. Do not start, stop, or change treatment based on it. Reporting note. OTN reviewed the linked sources and documents listed above. The article identifies estimates, projections, unresolved questions, and the limits of the evidence.

Pomerantz law Firm announces the filing of a class action against Fractyl Health, Inc. and certain officers - GUTS. Sep 24, 2026, 17:39 ET NEW YORK, Sept. 24, 2026 /PRNewswire/ - Pomerantz LLP announces that a class action lawsuit has been filed against Fractyl Health, Inc. ("Fractyl" or the "Company") (NASDAQ: GUTS) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 26-cv-07167, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Fractyl securities between January 13, 2025 and January 29, 2026, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are an investor who purchased or otherwise acquired Fractyl securities during the Class Period, you have until October 20, 2026 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. Fractyl is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes and obesity. The Company is developing, inter alia, the Revita DMR System ("Revita"), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet. During the Class Period, Defendants were highly focused on advancing Revita through Fractyl's "REMAIN-1" study, evaluating Revita's efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy. The REMAIN-1 study is designed to include three distinct patient cohorts: (i) the REVEAL-1 Cohort; (ii) the REMAIN-1 Midpoint Cohort; and (iii) the REMAIN-1 Pivotal Cohort. At all relevant times, Defendants touted Revita's efficacy as observed in interim data readouts from the REVEAL-1 and REMAIN-1 Midpoint Cohorts, while highlighting data from prior studies that likewise evaluated Revita's ability to reduce weight gain under other circumstances. Defendants variously characterized such data as "groundbreaking", "clinically and statistically significant", and "striking", while highlighting the purported "[c]lear evidence of Revita activity". (Emphasis in original.) In August and September 2025, on days coinciding with the release of positive data readouts purportedly demonstrating Revita's efficacy potential, Defendants announced public offerings of Fractyl securities, reaping tens of millions of dollars in proceeds, piggybacking on the hype generated by these purportedly promising results. The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Revita was less effective than Defendants had led investors to believe, and/or operational issues at one or more of the REMAIN-1 Midpoint Cohort's clinical sites compromised the integrity of its efficacy results; (ii) accordingly, Revita's clinical, regulatory, and commercial prospects were overstated, as was the REMAIN-1 Midpoint Cohort's ability to assess Revita's efficacy; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times. The truth began to emerge on January 29, 2026, when, during pre-market hours, Fractyl issued a press release announcing six-month data from the REMAIN-1 Midpoint Cohort. The press release disclosed, in relevant part, that "[a]cross the prespecified efficacy population..., Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months", representing a significantly more modest efficacy result than previously disclosed results and falling short of investor expectations, while stating that "[t]he Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis[.]" The same day, also during pre-market hours, Fractyl hosted a conference call with investors and analysts to discuss the six-month data from the REMAIN-1 Midpoint Cohort. During the call, Fractyl's Chief Executive Officer Defendant Harith Rajagopalan ("Rajagopalan") indicated that issues at one of the REMAIN-1 Midpoint Cohort study sites, which "had higher-than-expected regain across both arms," were at least partly to blame for the cohort's disappointing six-month efficacy results. Following these disclosures, Fractyl's stock price fell $1.245 per share, or 68.03%, to close at $0.585 per share on January 29, 2026. The same day, during post-market hours, Canaccord Genuity issued a report on Fractyl, providing additional color on the site-specific issue identified by Defendant Rajagopalan. Specifically, the report cited a "call with mgmt [that] clarified some of the key FAQs around the 'outlier site'", stating that Fractyl "attribute[d] the variability in the 1 outlier site (out of 6) to a relatively less robust diet and lifestyle counseling program", noting that "[t]his site was the first to enroll and hadn't yet set up a dietary center." Also on January 29, 2026, during post-market hours, Morgan Stanley issued a report on Fractyl, downgrading the Company to an "Equal-weight" from "Overweight" rating and cutting its price target on the Company's stock to $2.00 from $8.00. The report characterized the latest REMAIN-1 Midpoint Cohort study results as "[d]isappoint[ing]", noting that the "[r]andomized 6mo results for Revita in weight maintenance showed trends, but fell short of expectations, raising questions." Specifically, the report noted that "Revita patients experienced 4.5% weight regain (+1.5% in open label cohort) vs. 7.5% sham (~10% expected)", which "represents a 40% delta vs. sham, below the 50% threshold, suggesting more modest benefits, though was negatively impacted by a single site." Notwithstanding Defendants' "indicat[ion that the] results were negatively impacted by a single site," the report concluded that "we take a more cautious view on the potential of Revita and move to the sidelines", and "[g]iven our more cautious view, we lower our probability of success for Revita to 35% from 50%, previously" and "now model peak risk-adjusted worldwide sales of ~$490M in 2035 (previously $700M)[.]" Following the release of the Canaccord Genuity and Morgan Stanley reports, Fractyl's stock price fell $0.125 per share, or 21.37%, to close at $0.46 per share on January 30, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. SOURCE Pomerantz LLP