{"filings":[{"id":1645881,"accession_number":"0001193125-26-303948","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-07-15T10:00:36+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).","Complete duodenal ablation (>14 cm) maintained ~81% of GLP-1-induced weight loss vs 48% sham (4.8% vs 13.0% regain).","Optimized patients (≥17.5% run-in loss) maintained ~84% vs 46% (4.1% vs 13.5% regain); responder rate 73% mITT, 91% complete ablation.","No device/procedure-related serious adverse events; TEAE rates comparable (24% Revita vs 25% sham).","Next milestones: topline Pivotal Cohort data early Q4 2026; potential FDA De Novo submission late Q4 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":1002398,"accession_number":"0001193125-26-267897","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-06-11T21:15:16+00:00","items":["5.07"],"status":"ready","headline":"Fractyl Health annual meeting elects three Class II directors, ratifies EY as auditor","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Marc Elia, Clive Meanwell, and Ian Sheffield elected as Class II directors for three-year terms ending 2029.","Ernst & Young LLP ratified as independent auditor for fiscal year ending December 31, 2026.","Approximately 70.7% of outstanding shares represented at the meeting; 112.2 million shares voted."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":842956,"accession_number":"0001193125-26-256445","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-06-04T11:05:16+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health reports positive 1-year REVEAL-1 data: ~78% weight maintenance post-GLP-1 with Revita.","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Participants retained ~78% of prior GLP-1-induced weight loss at one year after single Revita procedure.","33% of patients continued losing weight at one year; mean weight change 5.3% (n=15) vs ~15% regain with GLP-1 withdrawal alone.","No procedure-related serious adverse events; mild events occurred in 36% of participants, all transient.","Next data readouts: REMAIN-1 Midpoint Cohort randomized data Q3 2026, REMAIN-1 Pivotal Cohort topline Q4 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":40202,"accession_number":"0001193125-26-219365","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-05-12T20:05:16+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q1 net income $9.2M on non-cash warrant change; Revita pivotal data on track for early Q4","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q1 R&D expenses $15.6M (down from $19.4M YoY); SG&A $5.2M; adjusted EBITDA -$18.0M.","Cash $63.2M; runway into early 2027, beyond anticipated pivotal data readout.","Revita REMAIN-1 Pivotal topline 6-month data expected early Q4 2026; FDA De Novo submission target late Q4 2026.","1-year REVEAL-1 Cohort data in Q2 2026; 1-year randomized REMAIN-1 Midpoint data in Q3 2026.","RJVA-001 first-in-human dosing and preliminary data expected in H2 2026 after Netherlands CTA authorization."],"consensus_eps_estimate":-0.1632,"consensus_eps_actual":0.06,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":93765,"accession_number":"0001193125-26-215662","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-05-11T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health gets Dutch authorization for first-in-human trial of RJVA-001 gene therapy for T2D","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Received Clinical Trial Application authorization in the Netherlands for Phase 1/2 first-in-human study of RJVA-001.","RJVA-001 is the first AAV gene therapy candidate to enter clinical development for type 2 diabetes.","First patient dosing and preliminary data expected in the second half of 2026, subject to site activation.","Rejuva clinical development funded within existing cash runway into early 2027; no change to capital plans.","Fractyl becomes dual clinical-stage with Revita in pivotal development and Rejuva entering first-in-human studies."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105652,"accession_number":"0001193125-26-121780","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-03-24T23:59:59+00:00","items":["2.02","7.01","9.01"],"status":"ready","headline":"Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.","Cash $81.5M as of Dec 31, 2025; cash runway into early 2027 beyond pivotal readout.","Completed REMAIN-1 Pivotal Cohort randomization; topline 6-month data expected early Q4 2026.","FDA feedback supports Class II De Novo pathway; potential De Novo submission late Q4 2026.","Post-hoc analyses show ablation-length-dependent treatment effect; 70% reduction in weight regain in above-median GLP-1 loss group."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105651,"accession_number":"0001193125-26-110923","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-03-17T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"Fractyl Health receives Nasdaq bid-price deficiency notice; 180 days to cure","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Received Nasdaq letter on March 13, 2026 for bid price below $1.00 for 30 consecutive business days.","Has until September 9, 2026 to regain compliance by closing at $1.00+ for 10 consecutive business days.","May transfer to Nasdaq Capital Market or effect reverse stock split if needed; no immediate delisting.","Company intends to monitor and consider options; no assurance of maintaining listing."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105650,"accession_number":"0001193125-26-073374","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-02-26T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health completes randomization in REMAIN-1 pivotal trial for Revita; topline data expected early Q4 2026","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.","Topline 6-month pivotal data expected early Q4 2026; potential FDA marketing submission late Q4 2026.","Cash runway reiterated into early 2027, beyond pivotal readout.","Anticipated milestones: Q2 2026 FDA feedback on De Novo pathway, 1-year data from REVEAL-1 and REMAIN-1 Midpoint Cohort."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105649,"accession_number":"0001193125-26-028228","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-01-29T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Revita-treated patients (n=40) had 4.5% weight regain vs 7.5% sham at 6 months (p=0.07) in REMAIN-1 Midpoint Cohort.","In above-median GLP-1 weight loss subgroup, Revita achieved 70% relative reduction in weight regain vs sham (p=0.004).","Revita improved cardiometabolic markers: HDL +15.5 vs +3.9 mg/dL (p=0.01) and reduced sweet-food cravings (p=0.04).","No serious adverse events related to Revita; no study discontinuations due to adverse events through 6 months.","Fractyl requested FDA feedback on De Novo reclassification for Revita; feedback expected Q2 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105648,"accession_number":"0001193125-26-003452","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-01-06T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"Fractyl Health appoints Lara Smith Weber as CFO; Lisa Davidson resigns effective Dec 31, 2025","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Lara Smith Weber appointed CFO effective Jan 12, 2026; succeeds Lisa Davidson who resigned effective Dec 31, 2025.","Weber receives signing bonus of $150,000, base salary of $492,100, 40% target annual bonus, and option for 1,036,800 shares.","Davidson receives separation benefits: $450,000 salary continuation, $180,000 bonus, COBRA for 18 months, full time-vesting acceleration.","Davidson to provide consulting services for up to 3 months post-separation at $400/hour.","Weber previously CFO of Inari (Oct 2023-Jan 2026), ONWARD Medical, and U.S. CFO at MorphoSys."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":105647,"accession_number":"0001193125-26-001492","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2026-01-05T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Fractyl Health outlines 2026 milestones for Revita and Rejuva; cash $85.6M","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Preliminary unaudited cash $81.5M at Dec 31, 2025; plus $4.1M from Tranche A warrant exercises on Jan 2, 2026 gives $85.6M.","Revita: 6-month randomized REMAIN-1 Midpoint data due late Jan 2026; potential PMA filing in H2 2026.","Rejuva: RJVA-001 first-in-human dosing expected in H2 2026 subject to CTA authorization; regulatory feedback in Q2 2026.","Cash runway projected through early 2027 to fund all planned 2026 clinical and regulatory milestones."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":121943,"accession_number":"0001193125-25-319524","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-12-16T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health calls 17.1M Tranche A Warrants at $1.05; stock at $2.24, deadline Dec 30","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["17,063,073 Tranche A Warrants outstanding; exercise price $1.05; stock closed at $2.24 on Dec 15.","Holders must exercise by 6:30 p.m. ET on Dec 30, 2025; unexercised warrants cancelled for $0.00001 each.","If all warrants exercised, company would receive ~$17.9M in gross proceeds to strengthen balance sheet.","Call enabled by achievement of VWAP >$1.37 for 15 consecutive days and avg daily volume >$2M, plus REMAIN-1 data release Sep 26.","Warrants issued in August 2025 public offering; shares underlying warrants registered under SEC File 333-285522."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":121942,"accession_number":"0001193125-25-304486","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-12-02T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Participants who lost ~24% body weight on GLP-1 drugs had mean 1.5% weight change at 6 months after Revita (n=17), vs ~10% regain in literature.","HbA1c change was 0.04% after Revita vs ~0.4% increase in STEP-1 extension; no procedure-related serious adverse events.","Upcoming catalysts: Jan 2026 REMAIN-1 6-month randomized data; H2 2026 pivotal topline data and potential PMA filing.","Revita received FDA Breakthrough Device designation for post-GLP-1 weight maintenance.","Average ablation length ~16 cm, consistent with prior experience, supporting scalability."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":121941,"accession_number":"0001193125-25-277524","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-11-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q3 net loss $45.6M; Revita post-GLP-1 weight maintenance data positive","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $45.6M includes $23.5M non-cash warrant fair-value change; operating expenses down $1.1M YoY.","R&D spend $17.5M vs $19.0M year-ago; SG&A $5.2M vs $4.8M.","Cash $77.7M at Sep 30 2025; $83M in August/September offerings extend runway into early 2027.","REMAIN-1 Midpoint Cohort met endpoint: Revita patients lost 2.5% additional weight vs 10% regain for sham (p=0.014).","REMAIN-1 Pivotal enrollment >60% randomized; 6-month primary data expected H2 2026 with potential PMA filing."],"consensus_eps_estimate":-0.3223,"consensus_eps_actual":-1.79,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl+finnhub","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":121940,"accession_number":"0001193125-25-230096","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-10-03T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"Fractyl Health stockholders approve share issuance for warrant exercise at special meeting","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Proposal 1 approved with 31,735,506 votes for (98.4% of votes cast) to issue shares upon warrant exercise from Aug 7 financing.","Proposal 2 (adjournment if needed) also approved with 31,744,878 votes for to allow additional proxy solicitation.","Special meeting held Oct 3, 2025; 32,249,473 shares represented (64.12% of outstanding 50,289,014 shares).","Warrant exercise relates to financing that closed Aug 7, 2025; issuance required Nasdaq approval under Listing Rule 5635(d)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.15,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":138638,"accession_number":"0001193125-25-218515","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-09-26T23:59:59+00:00","items":["1.01","7.01","9.01"],"status":"ready","headline":"Fractyl Health prices $60M public offering of 60M shares at $1.00/share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering of 60M shares of common stock at $1.00 per share; gross proceeds ~$60M, net ~$56M.","Expected to close on or about September 29, 2025, subject to customary conditions.","Net proceeds, with existing cash, expected to fund operating expenses into early 2027.","BofA Securities and Evercore ISI acting as joint book-running managers; Ladenburg Thalmann as lead manager.","Shelf registration statement (333-285522) effective March 18, 2025; prospectus supplement to be filed."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":138637,"accession_number":"0001193125-25-218508","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-09-26T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl's Revita maintains weight loss after GLP-1 stop; 2.5% further loss vs 10% regain in sham (p=0.014)","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Revita-treated patients (n=29) lost additional 2.5% total body weight at 3 months after stopping tirzepatide; sham (n=16) regained 10% (p=0.014).","No Revita-related SAEs or Grade II+ AEs observed; side effects mild/transient, consistent with prior studies.","REMAIN-1 Midpoint Cohort ongoing; 6-month data expected Q1 2026.","Pivotal cohort randomization on track for early 2026; 6-month topline data and potential PMA filing in H2 2026.","Results provide first randomized, blinded evidence of durable drug-free weight maintenance post-GLP-1."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":138636,"accession_number":"0000950170-25-112671","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-09-03T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Fractyl Health appoints Dr. Christopher Thompson and Ian Sheffield to board; Amy Schulman resigns","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Christopher Thompson, M.D. appointed as Class I director effective Sept 2, 2025.","Ian Sheffield appointed as Class II director and to audit committee effective Sept 2, 2025.","Each receives $43,500 annual retainer; Sheffield gets additional $10,000 for audit committee; initial option for 45,000 shares vesting over 3 years.","Amy W. Schulman resigned as Class I director and from nominating committee effective Sept 2, 2025; no dispute with company."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":138635,"accession_number":"0000950170-25-107295","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-08-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q2 2025 net loss $27.9M; $23M offering extends cash runway into 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss for Q2 2025 was $27.9 million, compared to $17.2 million in Q2 2024, driven by higher R&D spending and non-cash changes.","Completed $23 million underwritten public offering in August 2025, with potential additional $46 million from warrants.","Cash and cash equivalents were $22.3 million as of June 30, 2025; post-offering cash runway extends into 2026.","Positive 3-month REVEAL-1 Cohort data: 12 of 13 participants maintained weight after GLP-1 discontinuation with Revita.","Enrollment completed for REMAIN-1 Midpoint Cohort (45 participants); 3-month randomized data expected September 2025."],"consensus_eps_estimate":-0.3672,"consensus_eps_actual":-1.05,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":138634,"accession_number":"0001193125-25-175581","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-08-07T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Fractyl Health closes $20.7M underwritten offering of common stock and warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Issued 19,047,619 shares and warrants to buy up to 38,095,238 shares at combined price of $1.05/unit.","Net proceeds of ~$20.7M; funds to support Revita and Rejuva pipeline programs and working capital.","Tranche A warrants exercisable at $1.05, 2-year term; callable after REMAIN-1 data if stock >$1.37 for 15 days.","Tranche B warrants require stockholder approval, 5-year term; directors, officers, Mithril agreed to vote in favor.","Underwriter exercised full over-allotment for additional 2,857,142 units, increasing total offering size."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156092,"accession_number":"0000950170-25-088710","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-06-23T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health: Revita shows 92% weight maintenance post-GLP-1; Rejuva prevents obesity in mice","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["12 of 13 Revita participants maintained or lost weight at 3 months after stopping GLP-1; median weight stable (0.46% change).","No serious adverse events with Revita; REMAIN-1 Midpoint cohort data expected Q3 2025 and Pivotal cohort H2 2026.","Rejuva single dose prevented obesity and hyperglycemia in high-fat diet mice; 20% weight reduction and 38% glucose decrease.","Rejuva RJVA-001 progressing toward first-in-human studies; preliminary clinical data anticipated in 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156091,"accession_number":"0000950170-25-087678","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-06-18T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health gets two new U.S. patents for duodenal resurfacing, portfolio now 31 granted patents","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["U.S. Patent No. 12,329,439 (June 17, 2025) and No. 12,303,185 (May 20, 2025) cover thermal and non-thermal electrical energy ablation of duodenal mucosa.","Total IP estate: 31 granted U.S. patents and ~40 pending applications, built since 2011.","Revita next milestones: REVEAL-1 open-label data June 2025, REMAIN-1 midpoint Q3 2025, primary endpoint H2 2026.","Patents reinforce Fractyl's leadership in gut-targeted metabolic therapies for obesity and type 2 diabetes."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156090,"accession_number":"0000950170-25-085375","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-06-12T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"Fractyl Health stockholders elect three Class I directors, ratify Ernst & Young as auditor at annual meeting","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Class I directors elected: William W. Bradley, Ajay Royan, Amy W. Schulman – each with over 24.3M votes for.","Ratification of Ernst & Young as independent auditor for FY2025 passed: 34.2M for, 36.7K against, 230K abstain.","70.38% of outstanding shares (34.5M of 49.0M) were represented at the June 11, 2025 annual meeting."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156089,"accession_number":"0000950170-25-073988","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-05-19T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health submits first CTA module in Europe for RJVA-001 gene therapy in type 2 diabetes","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Submitted first Clinical Trial Application module in Europe for RJVA-001, a gene therapy for type 2 diabetes.","Expects to dose first patients and report preliminary data in 2026, pending CTA authorization.","Phase 1/2 study: open-label, dose escalation; primary endpoints safety/tolerability, secondary HbA1c and fasting glucose.","Preclinical data (ASGCT 2025) showed safety, dose-dependent potency, adaptive nutrient-responsive secretion with low circulating GLP-1.","Company targets durable disease remission via one-time therapy, reducing burden of lifelong injectable GLP-1 drugs."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156088,"accession_number":"0000950170-25-073945","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-05-19T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health presents preclinical data for RJVA-001 gene therapy; CTA submission expected June 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.","Systemic GLP-1 levels 10-20 pM, >5-fold lower than pharmacologic GLP-1 drugs (50-150 pM), potentially reducing side effects.","Nutrient-responsive GLP-1 secretion demonstrated in human beta cells and islets, mimicking natural hormone regulation.","Endoscopic ultrasound delivery in pigs achieved targeted pancreatic expression in <20 min with no observed toxicity.","First CTA module submission for RJVA-001 expected by June 2025; preliminary human data anticipated in 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156087,"accession_number":"0000950170-25-070294","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-05-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $23.7M vs $3.3M YoY, driven by non-cash fair value change and $3.2M operating expense increase.","Cash $42.1M expected to fund operations into Q4 2025; R&D expenses rose to $19.4M from $14.4M.","REMAIN-1 Pivotal Cohort (315 patients) enrollment completed ahead of schedule; 6-month primary endpoint data H2 2026.","REVEAL-1 3-month open-label data update expected June 2025; REMAIN-1 Midpoint Cohort data Q3 2025.","Rejuva gene therapy advancing; first CTA module submission for RJVA-001 expected June 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.49,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156086,"accession_number":"0000950170-25-048033","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-04-01T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Fractyl Health reports early REVEAL-1 data suggests Revita prevents weight regain after GLP-1 stop","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First 7 patients showed average weight regain of 1.2% at 1 month vs typical ~3% after GLP-1 discontinuation.","No safety or tolerability concerns in 15 patients treated to date; consistent with prior pooled data.","REMAIN-1 pivotal study now >50% enrolled; full enrollment expected summer 2025; midpoint analysis Q3 2025.","Revita holds FDA Breakthrough Device designation for post-GLP-1 weight maintenance.","Additional REVEAL-1 follow-up data expected in Q2 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":174536,"accession_number":"0000950170-25-038683","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-03-13T23:59:59+00:00","items":["5.08","8.01"],"status":"ready","headline":"Fractyl Health sets June 11, 2025 annual meeting; proposal deadline March 23","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Annual meeting scheduled for June 11, 2025; details in proxy statement.","No annual meeting held in 2024; deadlines triggered by March 13 announcement.","Stockholder proposals for proxy inclusion due by March 23, 2025.","Director nominations and other business notices also due March 23, 2025 per bylaws and Rule 14a-19."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":174535,"accession_number":"0000950170-25-030826","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-03-03T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health reports Q4 2024 net loss $25.0M; REMAIN-1 enrollment surges to 189+ patients","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q4 2024 net loss $25.0M vs $19.2M in Q4 2023; R&D expense rose to $20.3M from $10.1M.","Cash and equivalents $67.5M; cash runway extended into 2026 after pausing T2D Revita programs.","REMAIN-1 pivotal study enrolled >189 patients across 13 sites; midpoint data expected Q2 2025, full enrollment summer 2025.","Rejuva RJVA-001 CTA for T2D submission expected H1 2025; preliminary data (if authorized) in 2026.","Strategic shift: focus Revita on weight maintenance, pause T2D Revita programs (REVITALIZE-1, Germany Registry)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":174534,"accession_number":"0000950170-25-011430","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-01-31T23:59:59+00:00","items":["2.05","7.01","9.01"],"status":"ready","headline":"Fractyl Health prioritizes Revita weight maintenance, Rejuva gene therapy; cuts 17% workforce","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["REMAIN-1 pivotal study for weight maintenance post-GLP-1 withdrawal; midpoint data analysis expected Q2 2025, full enrollment summer 2025.","Rejuva gene therapy candidate RJVA-001 completed key preclinical studies; first-in-human studies planned H1 2025.","Pausing Revita T2D programs (REVITALIZE-1 and German Real-World Registry) to focus resources.","Workforce reduction of 22 employees (~17%) with estimated severance costs of $1.8M; cash runway extended into 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":174533,"accession_number":"0000950170-25-004554","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2025-01-13T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health: initial REVEAL-1 data show weight maintenance post-GLP-1 discontinuation; REMAIN-1 enrollment strong","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First REVEAL-1 patient achieved 15% total body weight loss on tirzepatide, then maintained weight 1 month after Revita post-discontinuation.","Prior studies show average 3% weight regain within 4 weeks of GLP-1 discontinuation, highlighting Revita potential.","Over 100 patients enrolled across 8 sites in REMAIN-1 study in less than 4 months; high demand.","REVEAL-1 cohort data presentation delayed to Q1 2025 due to holiday scheduling; mid-point analysis expected Q2 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":191497,"accession_number":"0000950170-24-125329","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-11-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q3 net loss $23.2M; cash $84.7M; Revita studies on track","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $23.2M vs $15.7M YoY; R&D expense $19.0M (up from $9.4M) on clinical progress.","Cash and equivalents $84.7M; expected to fund operations into Q4 2025.","REMAIN-1 mid-point analysis expected Q2 2025; REVEAL-1 open-label data start Q4 2024.","REVITALIZE-1 topline data expected mid-2025; RJVA-001 CTA submission by YE 2024.","Nominated RJVA-002, first smart GIP/GLP-1 pancreatic gene therapy candidate for obesity."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.09,"consensus_revenue_estimate":null,"consensus_revenue_actual":90000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":191496,"accession_number":"0000950170-24-120706","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-11-04T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health nominates RJVA-002 GIP/GLP-1 gene therapy; positive 13-week preclinical data on RJVA-001","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Nominated RJVA-002 as first GIP/GLP-1 pancreatic gene therapy lead candidate for obesity.","RJVA-001 shows sustained weight and blood sugar control at 13 weeks in DIO mice on high-fat diet.","Over 10% of islet cells expressed GLP-1 after single dose; no safety signals.","Data independently validated by Dr. Randy Seeley at University of Michigan.","Fractyl plans to use durable efficacy results for RJVA-001 FIH data package."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":207977,"accession_number":"0000950170-24-096983","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-08-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Net loss of $17.2M vs $30.2M in Q2 2023; cash and equivalents $102.4M as of June 30, 2024.","FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 discontinuation.","REMAIN-1 pivotal study for Revita initiated; open label data expected Q4 2024; midpoint analysis Q2 2025.","REVITALIZE-1 on track to report topline data mid-2025 in expanded T2D population (protocol amendment approved).","Chairman Allan Will stepped down; Ajay Royan appointed new Chair effective August 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":207976,"accession_number":"0000950170-24-087501","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-07-30T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"FDA grants Breakthrough Device Designation for Fractyl's Revita in weight maintenance after GLP-1 discontinuation","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.","Breakthrough Device Designation enables priority FDA review and potential CMS reimbursement support.","REMAIN-1 pivotal study underway; data readouts expected starting Q4 2024, mid-point analysis Q2 2025.","Designation based on prior pooled weight data from T2D studies showing durable weight maintenance."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":225496,"accession_number":"0000950170-24-076424","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-06-24T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.","Midpoint data analysis for REMAIN-1 now anticipated in Q2 2025.","FDA approved protocol amendment for REVITALIZE-1: expands eligibility to any glucose lowering agent; potential U.S. treatment population ~6x to ~25M patients.","Topline data from REVITALIZE-1 expected mid-2025.","Preclinical data for Rejuva gene therapy vs semaglutide showed greater, more durable weight loss in mice; presented at ADA 84th Scientific Sessions."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":225495,"accession_number":"0000950170-24-058615","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-05-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q1 net loss $3.3M; cash $121.4M; Remain-1 pivotal study H2 2024","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $3.3M vs $11.9M YoY; includes $17.1M non-cash gain from fair value changes.","Cash and cash equivalents $121.4M as of March 31, 2024; expected to fund operations through 2025.","Expects to initiate Remain-1 pivotal study for weight maintenance after GLP-1 discontinuation in H2 2024.","Topline data from Revitalize-1 pivotal T2D study anticipated in Q4 2024; enrollment completion expected Q2 2024.","Appointed Adrian Kimber as Chief Commercial Officer; Germany registry study shows HbA1c reduction >1% and weight loss >15 lbs at 3 months."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.17,"consensus_revenue_estimate":null,"consensus_revenue_actual":33000.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":225494,"accession_number":"0001193125-24-082586","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-04-01T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Fractyl Health Receives FDA IDE Approval for Revita Pivotal Study in Weight Maintenance","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA approved Investigational Device Exemption for Revita Remain-1 pivotal study for weight maintenance after GLP-1RA discontinuation.","Remain-1 is a randomized, double-blind trial vs sham in patients who lost ≥15% body weight on tirzepatide; at least 315 subjects randomized 2:1.","Fractyl Health will also run Reveal-1 open-label cohort and provide updates in the second half of 2024.","Revita is an outpatient endoscopic procedure targeting duodenum aimed at durable weight loss without ongoing medical therapy.","CEO Harith Rajagopalan and Dr. Christopher Thompson highlighted the unmet need for durable weight maintenance solutions."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":225493,"accession_number":"0000950170-24-038865","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-04-01T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Fractyl Health Q4 2023: FDA approves IDE for Revita weight-maintenance study; gene therapy candidate RJVA-001 nominated","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.","Enrollment in Revitalize-1 T2D pivotal study expected to complete Q2 2024; topline data Q4 2024.","Announced RJVA-001 as first GLP-1 pancreatic gene therapy candidate; IND-enabling studies to complete H2 2024.","Completed IPO raising ~$100.3M net; cash on hand expected to fund operations through 2025.","FY 2023 net loss $77.1M vs $46.5M in 2022; revenue insignificant $0.1M; R&D expense $38.0M."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.17,"consensus_revenue_estimate":null,"consensus_revenue_actual":33000.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":244660,"accession_number":"0001193125-24-025262","cik":1572616,"company_name":"FRACTYL HEALTH, INC.","ticker":"GUTS","form_type":"8-K","filed_at":"2024-02-06T23:59:59+00:00","items":["5.03","8.01","9.01"],"status":"ready","headline":"Fractyl Health completes $110M IPO at $15/share, adopts amended charter and bylaws","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Closed IPO of 7,333,333 shares at $15.00 per share; gross proceeds ~$110M before expenses.","Amended charter authorized 300M shares common stock and 10M shares undesignated preferred.","Bylaws establish classified board, exclusive forum provisions, and eliminate cumulative voting.","Stockholder action by written consent prohibited; advance notice requirements for director nominations.","Two-thirds supermajority vote required to remove directors for cause or amend bylaws/charter provisions."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":130076450.08332866,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}