Recent 8-K filings for GUTS
Highest-materiality recent filing
Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation
- 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).
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Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).
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Fractyl Health annual meeting elects three Class II directors, ratifies EY as auditor
Marc Elia, Clive Meanwell, and Ian Sheffield elected as Class II directors for three-year terms ending 2029.
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Participants retained ~78% of prior GLP-1-induced weight loss at one year after single Revita procedure.
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Q1 R&D expenses $15.6M (down from $19.4M YoY); SG&A $5.2M; adjusted EBITDA -$18.0M.
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Fractyl Health gets Dutch authorization for first-in-human trial of RJVA-001 gene therapy for T2D
Received Clinical Trial Application authorization in the Netherlands for Phase 1/2 first-in-human study of RJVA-001.
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Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete
Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.
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Fractyl Health receives Nasdaq bid-price deficiency notice; 180 days to cure
Received Nasdaq letter on March 13, 2026 for bid price below $1.00 for 30 consecutive business days.
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Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.
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Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup
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.
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Fractyl Health appoints Lara Smith Weber as CFO; Lisa Davidson resigns effective Dec 31, 2025
Lara Smith Weber appointed CFO effective Jan 12, 2026; succeeds Lisa Davidson who resigned effective Dec 31, 2025.
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Fractyl Health outlines 2026 milestones for Revita and Rejuva; cash $85.6M
Preliminary unaudited cash $81.5M at Dec 31, 2025; plus $4.1M from Tranche A warrant exercises on Jan 2, 2026 gives $85.6M.
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Fractyl Health calls 17.1M Tranche A Warrants at $1.05; stock at $2.24, deadline Dec 30
17,063,073 Tranche A Warrants outstanding; exercise price $1.05; stock closed at $2.24 on Dec 15.
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Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance
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.
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Fractyl Health Q3 net loss $45.6M; Revita post-GLP-1 weight maintenance data positive
Net loss of $45.6M includes $23.5M non-cash warrant fair-value change; operating expenses down $1.1M YoY.
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Fractyl Health stockholders approve share issuance for warrant exercise at special meeting
Proposal 1 approved with 31,735,506 votes for (98.4% of votes cast) to issue shares upon warrant exercise from Aug 7 financing.
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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).
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Fractyl Health prices $60M public offering of 60M shares at $1.00/share
Offering of 60M shares of common stock at $1.00 per share; gross proceeds ~$60M, net ~$56M.
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Fractyl Health appoints Dr. Christopher Thompson and Ian Sheffield to board; Amy Schulman resigns
Christopher Thompson, M.D. appointed as Class I director effective Sept 2, 2025.
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Fractyl Health Q2 2025 net loss $27.9M; $23M offering extends cash runway into 2026
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.
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Fractyl Health closes $20.7M underwritten offering of common stock and warrants
Issued 19,047,619 shares and warrants to buy up to 38,095,238 shares at combined price of $1.05/unit.
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Fractyl Health: Revita shows 92% weight maintenance post-GLP-1; Rejuva prevents obesity in mice
12 of 13 Revita participants maintained or lost weight at 3 months after stopping GLP-1; median weight stable (0.46% change).
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Fractyl Health gets two new U.S. patents for duodenal resurfacing, portfolio now 31 granted patents
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.
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Class I directors elected: William W. Bradley, Ajay Royan, Amy W. Schulman – each with over 24.3M votes for.
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Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.
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Fractyl Health submits first CTA module in Europe for RJVA-001 gene therapy in type 2 diabetes
Submitted first Clinical Trial Application module in Europe for RJVA-001, a gene therapy for type 2 diabetes.
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Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete
Net loss $23.7M vs $3.3M YoY, driven by non-cash fair value change and $3.2M operating expense increase.
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Fractyl Health reports early REVEAL-1 data suggests Revita prevents weight regain after GLP-1 stop
First 7 patients showed average weight regain of 1.2% at 1 month vs typical ~3% after GLP-1 discontinuation.
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Fractyl Health sets June 11, 2025 annual meeting; proposal deadline March 23
Annual meeting scheduled for June 11, 2025; details in proxy statement.
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Fractyl Health reports Q4 2024 net loss $25.0M; REMAIN-1 enrollment surges to 189+ patients
Q4 2024 net loss $25.0M vs $19.2M in Q4 2023; R&D expense rose to $20.3M from $10.1M.
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Fractyl Health prioritizes Revita weight maintenance, Rejuva gene therapy; cuts 17% workforce
REMAIN-1 pivotal study for weight maintenance post-GLP-1 withdrawal; midpoint data analysis expected Q2 2025, full enrollment summer 2025.
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First REVEAL-1 patient achieved 15% total body weight loss on tirzepatide, then maintained weight 1 month after Revita post-discontinuation.
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Fractyl Health Q3 net loss $23.2M; cash $84.7M; Revita studies on track
Net loss $23.2M vs $15.7M YoY; R&D expense $19.0M (up from $9.4M) on clinical progress.
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Nominated RJVA-002 as first GIP/GLP-1 pancreatic gene therapy lead candidate for obesity.
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Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation
Net loss of $17.2M vs $30.2M in Q2 2023; cash and equivalents $102.4M as of June 30, 2024.
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Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.
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Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility
REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.
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Fractyl Health Q1 net loss $3.3M; cash $121.4M; Remain-1 pivotal study H2 2024
Net loss $3.3M vs $11.9M YoY; includes $17.1M non-cash gain from fair value changes.
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FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.
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Fractyl Health Receives FDA IDE Approval for Revita Pivotal Study in Weight Maintenance
FDA approved Investigational Device Exemption for Revita Remain-1 pivotal study for weight maintenance after GLP-1RA discontinuation.
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Fractyl Health completes $110M IPO at $15/share, adopts amended charter and bylaws
Closed IPO of 7,333,333 shares at $15.00 per share; gross proceeds ~$110M before expenses.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.70 · Most common event other_material