$GUTS News
Last published 5h ago
- 5h agoGUTSFRACTYL HEALTH, INC. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 6d agoGUTSFractyl Health to Report Third Quarter 2026 Financial Results and Provide Business Updates on November 12, 2026GlobeNewswireBURLINGTON, Mass., Nov. 06, 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
- 6d agoGUTSFractyl Health to Report Third Quarter 2026 Financial Results and Provide Business Updates on November 12, 2026GlobeNewswireBURLINGTON, Mass., Nov. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic...
- 1w agoGUTSFractyl Health Strengthens Revita Patent Portfolio as It Advances Toward FDA Submission and Potential CommercializationGlobeNewswirePatent milestones build on positive REMAIN-1 six-month pivotal results and patient research supporting interest in a one-time procedure for post-GLP-1 weight maintenanceNew catheter patent provides protection extending
- 2w agoGUTSFractyl Health Announces Market Research Highlighting Substantial Patient Interest in a One-Time Procedural Approach to Post-GLP-1 Weight MaintenanceGlobeNewswireCompany estimates approximately one million U.S. patients each month discontinue GLP-1 medications and face the risk of weight regainOne-third of surveyed GLP-1 users expressed a preference for an endoscopic procedure
- 3w agoGUTSFractyl Health Sharpens Focus on Revita Following Positive Pivotal Results, Advancing Toward Planned FDA De Novo Submission in Post-GLP-1 Weight MaintenanceGlobeNewswireFollowing positive topline six-month REMAIN-1 pivotal results, Revita advancing toward planned FDA De Novo submission in late Q4 2026 and anticipated 12-month pivotal data readout in Q1 2027 Workforce reduction
- 3w agoGUTSINVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Fractyl Health, Inc. to Contact Law FirmPR NewswireFractyl Health, Inc. (NASDAQ:GUTS) shareholders should email fletcher@fmoorelaw.comNEW YORK, Oct. 19, 2026 /PRNewswire/ -- What is the Investigation
- 3w agoGUTSFractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 DiscontinuationGlobeNewswireREMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham 32% of Revita® participants in
- 1mo agoGUTSKuehn Law Encourages Investors of Fractyl Health, Inc. to Contact Law FirmPR NewswireKuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Fractyl Health, Inc. (NASDAQ: GUTS)...
- 1mo agoGUTSSueWallSt Reminds Shareholders of a Lead Plaintiff Deadline of October 20, 2026 in Fractyl Health, Inc. Lawsuit - GUTSGlobeNewswireTwo named officers of Fractyl Health, Inc. — Co-Founder and CEO Harith Rajagopalan and former CFO Lisa A. Davidson — face Section 20(a) control person claims over allegedly overstated Revita DMR efficacy data, after
- 1mo agoGUTSMorgan Stanley 24th Annual Global Healthcare Conference - FRACTYL HEALTH INCEarnings Call TranscriptsAll right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Goltz, one of the biotech analysts here, and it's my pleasure to introduce Harith Rajagopalan, C
- 1mo agoGUTSMorgan Stanley 24th Annual Global Healthcare Conference - FRACTYL HEALTH INCEarnings Call TranscriptsAll right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Goltz, one of the biotech analysts here, and it's my pleasure to introduce Harith Rajagopalan, C
- 1mo agoGUTSFractyl Health - 1774227 - FRACTYL HEALTH INCEarnings Call TranscriptsAll right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Goltz, one of the biotech analysts here, and it's my pleasure to introduce Harith Rajagopalan, C
- 2mo agoGUTSFractyl Health to Participate in Upcoming September Investor ConferencesGlobeNewswireBURLINGTON, Mass., Sept. 09, 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
- 2mo agoGUTSFractyl Health to Host Virtual Commercial Strategy Day on Tuesday, September 1, 2026: The Potential Path to Commercializing Revita®, a Procedural Therapy for Post-GLP-1 Weight MaintenanceGlobeNewswireBURLINGTON, Mass., Aug. 20, 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
- 3mo agoGUTSCG 46TH ANNUAL GROWTH CONFERENCE - FRACTYL HEALTH INCEarnings Call TranscriptsGood morning, everyone. Thanks for joining again. We're going to go ahead and get started. My name is Whitney Egyem. I'm one of the biotech analysts here at Canaccord, and I am very pleased to be joined this morning by F
- 3mo agoGUTSCG 46TH ANNUAL GROWTH CONFERENCE - FRACTYL HEALTH INCEarnings Call TranscriptsGood morning, everyone. Thanks for joining again. We're going to go ahead and get started. My name is Whitney Egyem. I'm one of the biotech analysts here at Canaccord, and I am very pleased to be joined this morning by F
- 3mo agoGUTSFractyl Health 2Q 2026 Financial Results and Business Update Conference Call - FRACTYL HEALTH INCEarnings Call TranscriptsGood afternoon and welcome to Fractal Health's second quarter 2026 financial results and business update call. As a reminder, this conference call is being recorded. At this time, all participants are on listen-only mode
- 3mo agoGUTSFractyl Health Reports Second Quarter 2026 Financial Results and Business UpdatesGlobeNewswireOne-year REMAIN-1 Midpoint Cohort data show Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablations — the first randomized evidence
- 3mo agoGUTSFractyl Health to Report Second Quarter 2026 Financial Results and Provide Business Updates on August 10, 2026GlobeNewswireBURLINGTON, Mass., Aug. 03, 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
- 3mo agoGUTSFractyl Health to Participate in Upcoming Investor EventsGlobeNewswireBURLINGTON, Mass., July 22, 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
- 4mo agoGUTSFractyl Health Reports Positive Randomized Data from REMAIN-1 Midpoint Cohort Demonstrating Durable Weight Maintenance One Year After GLP-1 DiscontinuationGlobeNewswireUp to 84% of GLP-1 induced weight loss retained with Revita® versus 46% with sham at one year in patients receiving complete duodenal ablations Next anticipated Revita® milestones are topline six-month randomized data
- 5mo agoGUTSFractyl Health Reports Positive One-Year REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® ProcedureGlobeNewswireParticipants retained ~78% of GLP-1 induced total body weight loss one year after discontinuation and a single Revita procedure 5.3% mean weight change observed with Revita (n=15); published third-party studies after
- 5mo agoGUTSFractyl Health Appoints Mike Zumdahl as Senior Vice President, Market Access and Commercial StrategyGlobeNewswireBURLINGTON, Mass., June 01, 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
- 6mo agoGUTSFractyl Health Reports First Quarter 2026 Financial Results and Business UpdatesGlobeNewswireNext anticipated Revita® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month
- 6mo agoGUTSFractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 DiabetesGlobeNewswireAuthorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes
- 6mo agoGUTSFractyl Health to Report First Quarter 2026 Financial Results and Provide Business Updates on May 12, 2026, and Will Participate in an Upcoming Investor ConferenceGlobeNewswireBURLINGTON, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2
- 7mo agoIBRXFATEGUTSMBRXScalable Biotech Manufacturing Unlocks a $14B MarketPR NewswireUSANewsGroup.com News Commentary — The global cell therapy manufacturing market is hitting a pivotal inflection point. It's projected to surpass $7...
- 7mo agoGUTSFractyl Health 4Q 2025 Financial Results and Business Update Conference Call - FRACTYL HEALTH INCEarnings Call TranscriptsGood afternoon and welcome to Fractal Health's fourth quarter and full year 2025 financial results and business update call. As a reminder, this conference call is being recorded. At this time, all participants are on li
- 7mo agoGUTSFractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business UpdatesGlobeNewswireCompleted randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026 Reports
- 8mo agoGUTSFractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of Revita® for Post-GLP-1 Weight MaintenanceGlobeNewswireTopline 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
- 9mo agoGUTSFractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 DiscontinuationGlobeNewswireRevita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients
- 10mo agoGUTSFractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Post-GLP-1 Weight Maintenance Therapeutic CategoryGlobeNewswireRandomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 Approximately $85.6 million
- 11mo agoGUTSFractyl Health Announces Call of Tranche A Warrants Tied to August 2025 Public Offering Following Achievement of Clinical and Trading MilestonesGlobeNewswireBURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company" or "Fractyl"), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root
- 11mo agoGUTSFractyl Health Reports Positive 6-Month REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® ProcedureGlobeNewswireParticipants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment 1.5% mean weight change observed with Revita (n=17);
- 11mo agoGUTSFractyl Health to Participate in the 8th Annual Evercore Healthcare ConferenceGlobeNewswireBURLINGTON, Mass., Dec. 01, 2025 (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
- 1y agoGUTSFractyl Health Reports Third Quarter 2025 Results; Revita® Clinical Momentum Builds Toward 2026 Pivotal Readout and PMA Filing, Cash Runway Extended into Early 2027GlobeNewswirePositive randomized 3-month REMAIN-1 Midpoint Cohort data showed single Revita procedure maintained weight loss after GLP-1 discontinuation; 6-month data expected in Q1 2026 6-month data from open-label REVEAL-1 Cohort
- 1y agoGUTSFractyl Health to Report Third Quarter 2025 Financial Results and Provide Business Updates on November 12, 2025GlobeNewswireBURLINGTON, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and
- 1y agoLXEOMBRXACADGUTSBeyond Traditional Drugs: Novel Platforms Targeting Hard-to-Treat ConditionsPR NewswireEquity InsiderNews Commentary – Conventional small molecule approaches have struggled to address genetic defects and complex disease mechanisms,...
- 1y agoGUTSFractyl Health Announces Potent Preclinical Results from RJVA-002, a Dual GIP/GLP-1 Gene Therapy Candidate for ObesityGlobeNewswireRJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateauedPreclinical results show that a single point-in-time treatment with RJVA-002 has the potential to achieve
- 1y agoGUTSFractyl Health Announces Pricing of $60 Million Underwritten Offering of Common StockGlobeNewswire
- 1y agoGUTSFractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita® Maintained Weight Loss After GLP-1 DiscontinuationGlobeNewswirePilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients
- 1y agoGUTSFractyl Health Expands Board of Directors with Appointments of Industry Leaders to Advance Clinical Execution and Strategic GrowthGlobeNewswireBURLINGTON, Mass., Sept. 03, 2025 (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
- 1y agoGUTSFractyl Health, Inc. (GUTS) Q2 2025 Earnings Call TranscriptEarnings Call Transcripts
- 1y agoGUTSFractyl Health Announces Second Quarter 2025 Financial Results and Business UpdatesGlobeNewswireRandomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025 Positive 3-month REVEAL-1 Cohort data showed single Revita® procedure sustained weight loss after GLP-1 discontinuation; incremental
- 1y agoGUTSFractyl Health Announces Closing of $23 Million Underwritten Public Offering Including Full Exercise of Underwriter's Option to Purchase Additional SharesGlobeNewswireOffering included participation from leading institutional investors, including Nantahala Capital, ADAR1 Capital Management, Second Line Capital, 683 Capital, and SilverArc Capital Proceeds expected to extend cash
- 1y agoGUTSFractyl Health to Report Second Quarter 2025 Financial Results and Provide Business Updates on August 12, 2025, and Will Participate in an Upcoming Investor ConferenceGlobeNewswireBURLINGTON, Mass., Aug. 06, 2025 (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
- 1y agoGUTSFractyl Health Announces Pricing of $20 Million Underwritten Public OfferingGlobeNewswireBURLINGTON, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company" or "Fractyl"), a metabolic therapeutics company pioneering pattern-breaking approaches that treat root causes of
- 1y agoGUTSFractyl Health Announces Proposed Public OfferingGlobeNewswireBURLINGTON, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company" or "Fractyl"), a metabolic therapeutics company pioneering pattern-breaking approaches that treat root causes of
- 1y agoGUTSFractyl Health Reports Potent and Durable Two-Year Real-World Outcomes with Revita® Showing Sustained Weight Loss and Improved Glucose Control After a Single ProcedureGlobeNewswireTwo-year follow-up in Germany Real-World Registry study showed median 9.6% weight loss and 1.6% HbA1c reduction after a single Revita procedure in participants with type 2 diabetes, with no device- or procedure-related