{"filing":{"accession_number":"0001193125-26-303948","cik":"0001572616","ticker":"GUTS","company_name":"FRACTYL HEALTH, INC.","form":"8-K","filing_date":"2026-07-15","report_date":null,"primary_document":"guts-20260715.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526303948/guts-20260715.htm"},"events":[{"id":17985,"run_id":16138,"accession_number":"0001193125-26-303948","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Fractyl Health disclosed positive one-year clinical trial results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating that 81–84% of GLP-1-induced weight loss was retained versus 46–48% with sham, with excellent tolerability and no serious adverse events. The company anticipates FDA De Novo submission in late Q4 2026, representing a material clinical milestone for its lead product candidate.","company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","filing_date":"2026-07-15","form":"8-K","submitted_at":null,"items":[{"id":16656,"accession_number":"0001193125-26-303948","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Fractyl Health disclosed positive one-year clinical trial results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating that up to 84% of GLP-1-induced weight loss was retained versus 46% with sham at one year. This represents a material clinical milestone for a clinical-stage company's lead product candidate, with the company anticipating FDA De Novo submission in late Q4 2026. While this is clinical data rather than a traditional earnings release, it constitutes a material operational/strategic milestone that would affect investor assessment of the company's progress toward commercialization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T10:10:20.172929+00:00","company_name":"","ticker":null,"filing_date":""},{"id":16657,"accession_number":"0001193125-26-303948","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Fractyl Health disclosed positive one-year clinical trial results from its REMAIN-1 Midpoint Cohort for Revita, demonstrating that the device maintained 81–84% of GLP-1-induced weight loss versus 48% with sham, with excellent tolerability and no serious adverse events. This is a material clinical milestone for a clinical-stage company's lead product candidate, affecting investor assessment of regulatory and commercialization prospects. While not a traditional earnings release (the company is pre-revenue), the clinical readout is a significant operational and strategic development that would influence a reasonable investor's view of the company's pipeline and path to market.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T10:10:20.172929+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":16656,"accession_number":"0001193125-26-303948","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Fractyl Health disclosed positive one-year clinical trial results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating that up to 84% of GLP-1-induced weight loss was retained versus 46% with sham at one year. This represents a material clinical milestone for a clinical-stage company's lead product candidate, with the company anticipating FDA De Novo submission in late Q4 2026. While this is clinical data rather than a traditional earnings release, it constitutes a material operational/strategic milestone that would affect investor assessment of the company's progress toward commercialization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T10:10:20.172929+00:00","company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","filing_date":"2026-07-15"},{"id":16657,"accession_number":"0001193125-26-303948","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Fractyl Health disclosed positive one-year clinical trial results from its REMAIN-1 Midpoint Cohort for Revita, demonstrating that the device maintained 81–84% of GLP-1-induced weight loss versus 48% with sham, with excellent tolerability and no serious adverse events. This is a material clinical milestone for a clinical-stage company's lead product candidate, affecting investor assessment of regulatory and commercialization prospects. While not a traditional earnings release (the company is pre-revenue), the clinical readout is a significant operational and strategic development that would influence a reasonable investor's view of the company's pipeline and path to market.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T10:10:20.172929+00:00","company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","filing_date":"2026-07-15"}]}