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Fractyl CEO: Revita Procedure Significantly Reduces Weight Regain
"With one-year randomized data for the REMAIN-1 Midpoint Cohort and open label data for REVEAL-1 Cohort, we have the clearest evidence yet that a single Revita procedure can meaningfully reduce weight regain after GLP-1 discontinuation, with the greatest benefit observed in patients who received an adequate dose of duodenal ablation," said Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl. "Together with a favorable one-year safety profile and cash runway into early 2027, these results give us continued confidence in the design and execution of our ongoing REMAIN-1 Pivotal Cohort, with topline six-month data on track for early Q4 2026 and a potential FDA De Novo submission to follow later in the quarter. As we approach these anticipated milestones, we are also building the commercial infrastructure needed to bring Revita to the patients with the greatest need."
Fractyl Health Reports Positive Results from REMAIN-1 Trial
Fractyl Health announced positive one-year results from its REMAIN-1 Midpoint Cohort. The new results reinforce the potential of the Revita DMR System to be the first durable procedural therapy for post-GLP-1 weight maintenance. Key Findings include: Dose-dependent durability confirmed at one year: In the full modified intention-to-treat, or mITT, population, a single Revita procedure reduced weight regain by approximately 40% versus sham at one year. Participants who received complete duodenal ablation maintained approximately 81% of GLP-1-induced weight loss at one year, compared with 48% in sham participants, reflecting a reduction in weight regain of over 60% versus sham. This is consistent with earlier findings that more complete duodenal ablation drives greater treatment effect. Greatest benefit in patients with greatest need: In an optimized population of participants who received complete duodenal ablation and had higher GLP-1 run-in weight loss, Revita maintained approximately 84% of GLP-1-induced weight loss at one year versus 46% with sham. These results are consistent with the view that patients at greatest need may derive the greatest benefit from Revita due to their higher propensity for weight regain after GLP-1 discontinuation. Weight-maintenance responder rate: The second co-primary endpoint of the Pivotal Cohort, assessed against a FDA mandated pre-specified performance goal of greater than50%, measures the proportion of Revita patients maintaining at least 5% total body weight loss relative to their pre-tirzepatide weight at one year. As a reference point for the Pivotal Cohort, this responder rate was 73% in the Midpoint Cohort mITT population, rising to 91% in those with complete duodenal ablation. Excellent tolerability: No device- or procedure-related serious adverse events occurred. No new device-related treatment-emergent adverse events were observed between six and 12 months. Overall TEAE rates were comparable between arms through one year (24% Revita versus 25% sham), reflecting a generally mild peri-procedural adverse event profile that supports potentially broad outpatient use for Revita. One new diagnosis of type 2 diabetes occurred in the sham arm versus none with Revita.
Fractyl CEO: Revita Has Potential to Transform Weight Maintenance
"We believe Revita has the potential to offer a transformational new approach to durable weight maintenance and a clinically needed off ramp from GLP-1 therapy. Our first quarter results reflect continued execution across every dimension of our business toward that goal," said Harith Rajagopalan, co-founder and CEO of Fractyl. "Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort remains on track for early Q4 2026. This registrational study is prospectively designed and statistically powered to demonstrate Revita's potential effect across the full cohort, with enrichment in participants with higher run-in weight loss and longer ablation length. Ahead of that readout, we expect to report 1-year REVEAL-1 Cohort data in Q2 2026 and 1-year REMAIN-1 Midpoint Cohort randomized data in Q3 2026. Fractyl stands alone in developing the first potential procedural option for post-GLP-1 weight maintenance, and with cash runway into early 2027, we are funded beyond the anticipated pivotal data readout."
Biotech Stocks Summit Therapeutics and Fractyl Health See Substantial Increase in Search Activity
These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:Summit Therapeutics, 130.37% surge in interestFractyl Health, 66.4% surge in interestPipeline and key clinical candidates for these companies:Summit Therapeuticsis a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.Fractyl Healthis a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl's goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease.Recent news on these stocks:April 7Stifel initiated coverage of Summit Therapeutics with a Buy rating and $45 price target. The firm believes the company's ivonescimab, a "first-in-class" PD-1xVEGF bispecific antibody, is positioned to lead in what could be a $200B drug class. The growing strategic capital committed to "fast-followers" suggests scarcity value in Summit's competitive positioning, the analyst tells investors in a research note. Stifel thinks the "de-risking" of Summit's first-line lung cancer trials "could trigger an overdue re-rating" of the shares.Hear more from InvestingChannel by signing up for.About "Biotech Alert"The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem.This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.
Fractyl Health Completes Participant Randomization in REMAIN-1 Study
Fractyl Health announced completion of participant randomization in its REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita for weight maintenance following GLP-1 therapy discontinuation. "Completion of randomization in the REMAIN-1 Pivotal Cohort marks an important milestone as we advance Revita toward the definitive clinical evidence we believe will clearly establish its role in post-GLP-1 weight maintenance," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "This study was prospectively designed and statistically powered to demonstrate Revita's effect. The clinical insights from our REVEAL-1 and REMAIN-1 Midpoint Cohorts, as well as ongoing follow-up from our Germany Real-World Registry study, informed both the study design and our confidence in this program. With randomization now complete and our balance sheet positioned to support us through and beyond the pivotal readout, our focus is on disciplined execution as we prepare to report topline 6-month results in early Q4 2026. We are grateful to the participants, investigators, and clinical site teams whose commitment has made this progress possible."
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