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Fractyl Health, Inc.

GUTSFDA catalysts, PDUFA dates & pipeline intelligence
$4.23
▼ -0.22 · -4.87%

Financials

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52W LOW $0.3852W HIGH $6.17
Volume
300.54 K
Value Traded
1.07 M
Short % Float
1.98%
-13.31%Week
+560.94%1 Month
+433.62%3 Month
+819.57%6 Month
-93.38%5 Year
-93.38%All Time

Cash Data

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Key Stats

Market Cap
56.11 M
EPS (TTM)
-7.96
P/E Ratio
-
Ent. Value
8.97 M
Total Shares
13.26 M
Float Shares
11.34 M
Insiders
14.55%
Institutions
38.98%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

GUTS Catalyst Timeline

Dated clinical, regulatory and corporate events for Fractyl Health, Inc.

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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How GUTS actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

No drug pipeline

Fractyl Health, Inc. is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every GUTS program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Revita obesity and type 2 diabetes2026-03-25mean ablation length: 16 cm; mean total body weight loss: 18.3%Read MoreFractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business UpdatesRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
BRADLEY WILLIAMDirectorBuy 64,516 149,138 held$0.62 09/14/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
SILVERARC CAPITAL MANAGEMENT, LLC 0.1 % 1.30 M 1.64 M -3.74% ( -63.65 K)
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Options Data

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Option Chain Statistics

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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How GUTS ranks across every disease it competes in

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See how GUTS ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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GUTS News

GUTS
Sep 9, 2026
GUTSConferences/Events
▼ -6.6%on this news

Fractyl Health to Participate in Upcoming September Investor Conferences

Fractyl Health, a clinical-stage metabolic therapeutics company, announced its participation in two upcoming investor conferences. CEO Harith Rajagopalan will present at the H.C. Wainwright 28th Annual Global Investment Conference and the Morgan Stanley 24th Annual Global Healthcare Conference. The company focuses on innovative treatments for obesity and type 2 diabetes.

Read more →
GUTS
Aug 20, 2026
GUTSConferences/Events

Fractyl 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 Maintenance

Fractyl Health will host a virtual Commercial Strategy Day on September 1, 2026, to discuss the commercialization of Revita, a therapy for post-GLP-1 weight maintenance. Recent data from the REMAIN-1 Midpoint Cohort indicates significant weight maintenance after the procedure. The company aims to outline its market strategy and regulatory plans ahead of a potential FDA submission.

Read more →
GUTS
Aug 3, 2026
GUTSGeneral

Fractyl Health to Report Second Quarter 2026 Financial Results and Provide Business Updates on August 10, 2026

Fractyl Health, a clinical-stage metabolic therapeutics company, will report its second quarter 2026 financial results and provide business updates on August 10, 2026. The company focuses on innovative treatments for obesity and type 2 diabetes, with candidates Revita and Rejuva in development. A live webcast of the event will be available on their website.

Read more →
GUTS
Jul 22, 2026
GUTSConferences/Events

Fractyl Health to Participate in Upcoming Investor Events

Fractyl Health, a clinical-stage metabolic therapeutics company, announced participation in several investor conferences. CEO Harith Rajagopalan will engage in one-on-one meetings and a fireside chat at these events. The company is focused on innovative treatments for obesity and type 2 diabetes, including its lead candidates Revita and Rejuva.

Read more →
GUTS
Jul 15, 2026
GUTSPhases
▲ +13.7%on this news

Fractyl Health Reports Positive Randomized Data from REMAIN-1 Midpoint Cohort Demonstrating Durable Weight Maintenance One Year After GLP-1 Discontinuation

Fractyl Health has reported promising results from its REMAIN-1 Midpoint Cohort, showing that the Revita DMR System can effectively maintain weight loss in patients after discontinuing GLP-1 therapy. The study demonstrated a significant reduction in weight regain, with participants maintaining up to 84% of their weight loss. The company anticipates further data from the pivotal cohort in early Q4 2026 and plans to submit a De Novo marketing application to the FDA later that year.

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GUTS
Jun 4, 2026
GUTSPhases

Fractyl Health Reports Positive One-Year REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita Procedure

Fractyl Health reported promising one-year results from its REVEAL-1 clinical study, where participants maintained about 78% of their weight loss induced by GLP-1 medication after a single Revita procedure. Notably, 33% of participants continued to lose additional weight post-therapy. The study also indicated excellent tolerability of the Revita procedure, with no serious adverse events reported. Future data releases from the ongoing REMAIN-1 study are eagerly anticipated for further insights into the efficacy of Revita's approach to weight management after GLP-1 therapy cessation.

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GUTS
Jun 1, 2026
GUTSGeneral
▲ +7.6%on this newsshared move

Fractyl Health Appoints Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy

Fractyl Health, Inc. has appointed Mike Zumdahl as Senior Vice President of Market Access and Commercial Strategy. Zumdahl brings extensive experience in market access and health economics, having previously worked at Inari Medical and Novo Nordisk. His appointment comes as Fractyl prepares for the topline readout of its REMAIN-1 clinical trial and potential marketing application for its Revita product, which targets weight maintenance in patients who discontinue GLP-1 therapies. The company aims to leverage his expertise at this crucial juncture.

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GUTS
May 13, 2026
GUTSFDA Updates
▲ +29.2%on this news

Fractyl Health Reports First Quarter 2026 Financial Results and Business Updates

Fractyl Health reported its first quarter 2026 financial results, highlighting upcoming clinical milestones for its Revita and Rejuva programs. The company anticipates key data readouts in Q2 and Q3 2026, with a pivotal study's topline data expected in early Q4. Additionally, Fractyl has secured funding to support its initiatives through early 2027.

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GUTS
May 11, 2026
GUTSPhases

Fractyl 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 Diabetes

Fractyl Health has received authorization to initiate a Phase 1/2 first-in-human trial of RJVA-001, a gene therapy candidate for type 2 diabetes, in the Netherlands. This marks a significant advancement as RJVA-001 is the first AAV-based gene therapy to enter clinical development for this condition. The company expects to dose the first patient and report preliminary data in the second half of 2026.

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GUTS
May 5, 2026
GUTSConferences/Events

Fractyl Health to Report First Quarter 2026 Financial Results and Provide Business Updates on May 12, 2026, and Will Participate in an Upcoming Investor Conference

Fractyl Health, a clinical stage metabolic therapeutics company, is set to report its first quarter 2026 financial results and provide business updates on May 12, 2026. The event will be accessible via webcast. Additionally, CEO Harith Rajagopalan will present at the BofA Securities 2026 Health Care Conference on May 14, 2026, highlighting the company's commitment to transparency and investor relations.

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GUTS
Mar 25, 2026
GUTSFDA Updates
▲ +16.2%on this news

Fractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates

Fractyl Health reported its fourth quarter and full year 2025 financial results, highlighting the completion of randomization in the REMAIN-1 Pivotal Cohort and positive FDA feedback for its De Novo classification request. New analyses from the REMAIN-1 Midpoint Cohort demonstrated significant treatment effects related to ablation length and GLP-1 weight loss. The company anticipates topline data in early Q4 2026 and maintains a cash runway into early 2027.

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GUTS
Mar 17, 2026
GUTSGeneral

Fractyl Health to Report Fourth Quarter and Full Year 2025 Financial Results and Provide Business Updates on March 24, 2026

Fractyl Health, a clinical stage metabolic therapeutics company, will report its financial results for Q4 and the full year of 2025 on March 24, 2026. The company aims to provide updates on its business strategies and progress in treating obesity and type 2 diabetes. A live webcast will be available for interested stakeholders.

Read more →
GUTS
Feb 26, 2026
GUTSPhases
▼ -6.2%on this news

Fractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of Revita® for Post-GLP-1 Weight Maintenance

Fractyl Health has completed participant randomization in its REMAIN-1 Pivotal Cohort study, evaluating Revita for weight maintenance after GLP-1 therapy. The study aims to provide definitive evidence of Revita's effectiveness, with topline results expected in early Q4 2026. The company is financially equipped to support operations through key milestones, including a potential FDA submission.

Read more →
GUTS
Jan 29, 2026
GUTSFDA Updates
▼ -68%on this news

Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation

Fractyl Health announced promising six-month results from its REMAIN-1 Midpoint Cohort study, showing that patients treated with Revita maintained weight and improved their cardiometabolic profile after discontinuing GLP-1 therapy. The data suggests Revita may effectively address weight regain issues. The company is also seeking FDA feedback for reclassifying Revita under the De Novo pathway, with pivotal data expected in 2026.

Read more →
GUTS
Jan 6, 2026
GUTSGeneral

Fractyl Health Appoints Lara Smith Weber as Chief Financial Officer to Support Commercial-Stage Preparedness

Fractyl Health has appointed Lara Smith Weber as its new Chief Financial Officer, effective January 12, 2026, to bolster its commercial-stage operations. With over 20 years of experience in financial leadership, Ms. Smith Weber is set to help the company manage increasing regulatory and market complexities as it prepares for commercialization. This leadership transition comes after Lisa Davidson’s resignation, who had been instrumental in the firm's growth and public offering. Fractyl aims to revolutionize treatment for metabolic diseases, focusing on durable outcomes for patients.

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GUTS
Jan 5, 2026
GUTSGeneral
▼ -8.4%on this newsshared move

Fractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Post-GLP-1 Weight Maintenance Therapeutic Category

Fractyl Health has outlined its strategic goals for 2026, focusing on pivotal clinical and regulatory milestones for its Revita and Rejuva programs. The company anticipates significant data releases and potential PMA submissions, addressing the unmet need for post-GLP-1 weight maintenance therapies. With approximately $85.6 million in cash, Fractyl is well-positioned to execute its plans throughout the year.

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GUTS
Dec 15, 2025
GUTSGeneral

Fractyl Health Announces Call of Tranche A Warrants Tied to August 2025 Public Offering Following Achievement of Clinical and Trading Milestones

Fractyl Health announced the call of its Tranche A Warrants for cancellation or exercise by December 30, 2025. This decision follows the achievement of clinical milestones, including positive data from the REMAIN-1 study. The company could gain approximately $17.9 million if all warrants are exercised, strengthening its financial position for upcoming clinical data readouts.

Read more →
GUTS
Dec 2, 2025
GUTSPhases
▲ +17.9%on this news· ran to +31% by day 3

Fractyl Health Reports Positive 6-Month REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® Procedure

Fractyl Health reported positive results from its REVEAL-1 study, where participants who lost significant weight on GLP-1 drugs maintained stable weight for six months after a single Revita procedure. This suggests Revita's potential as a viable option for weight maintenance post-GLP-1 therapy. The company anticipates further data from its REMAIN-1 study in 2026.

Read more →
GUTS
Dec 1, 2025
GUTSConferences/Events

Fractyl Health to Participate in the 8th Annual Evercore Healthcare Conference

Fractyl Health, a company specializing in metabolic therapeutics, will participate in the 8th Annual Evercore Healthcare Conference. CEO Harith Rajagopalan will engage in a fireside chat on December 3, 2025. The conference aims to address the growing issues of obesity and type 2 diabetes, highlighting Fractyl's commitment to innovative treatment approaches.

Read more →
GUTS
Nov 12, 2025
GUTSGeneral

Fractyl Health Reports Third Quarter 2025 Results; Revita® Clinical Momentum Builds Toward 2026 Pivotal Readout and PMA Filing, Cash Runway Extended into Early 2027

Fractyl Health reported strong third quarter 2025 results, highlighting positive data from the REMAIN-1 Midpoint Cohort, which indicates that the Revita procedure can maintain weight loss after GLP-1 discontinuation. The company has also secured $83 million in funding, extending its cash runway into early 2027. Upcoming milestones include pivotal data from the REMAIN-1 Pivotal Cohort expected in H2 2026.

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About Fractyl Health, Inc.

Burlington, MA 73 employees fractyl.com
Headquarters3 VAN DE GRAAFF DRIVE, BURLINGTON, MA, 01803
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