| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
phase 1/2 data readout example | Phase 1/2 | — | Subscribe to access the data. | Gene Therapies | Endocrine System | ||
phase 1/2 data readout example | Phase 1/2 | — | Subscribe to access the data. | Gene Therapies | Endocrine System | ||
phase 1/2 data readout example | Phase 1/2 | — | Subscribe to access the data. | Gene Therapies | Endocrine System |
Recent Updates
Recently added Catalysts
Fractyl Health, Inc.$0.79
+0.02 (+2.34%)
F 10Pipeline Score MedTech · Clinical
Market Cap
144.31 M
EPS
-1.50
P/E Ratio
-
Value Trade
983.24 K
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
15.60 M
Operating CF
-22.48 M
Total Assets
99.39 M
Total Liabilities
78.01 M
Equity
21.38 M
D/E Ratio
12,345
-2.24 %
Week
56.13 %
1 Month
93.2 %
3 Month
-30.83 %
6 Month
-93.38 %
5 Year
-93.38 %
All Time
Cash Data
Cash Position
63.17 M
Monthly Burn
7.49 M
Runway
6.7 mo
Burn Trend
StableSEC Filing
May 12, 2026
Overview
Volume
642.15 K
52 Week Range
0.38 - 3.03
% held by Insiders
18.24 %
% held by Institutions
35.66 %
Enterprise Value
141.96 M
Total Shares
137.02 M
Short %
1.79 %
Float Shares
74.40 M
Company Description
locked
Upcoming Catalyst
Drug Pipeline Intelligence
F10
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 9%
Micro Cap (rank 830 of 911)
Percentile RankFractyl Health, Inc. has significant pipeline risk (10/100).
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
Revita | obesity and type 2 diabetes | — | 2026-03-25 | mean ablation length: 16 cm; mean total body weight loss: 18.3% Read More | Fractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates Read More | |
Revita | obesity and type 2 diabetes | — | 2026-03-25 | mean ablation length: 16 cm; mean total body weight loss: 18.3% Read More | Fractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates Read More | |
Revita | obesity and type 2 diabetes | — | 2026-03-25 | mean ablation length: 16 cm; mean total body weight loss: 18.3% Read More | Fractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in GUTS
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
GUTS Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
GUTSFractyl Health Reports Positive One-Year REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita Procedure Participants retained ~78% of GLP-1 induced total body weight loss one
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.
Read more →GUTS▲ +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.
Read more →GUTS▲ +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.
Read more →GUTSFractyl 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.
Read more →GUTSFractyl 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.
Read more →GUTS▲ +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.
Read more →GUTSFractyl 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▼ -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▼ -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 →GUTSFractyl 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.
Read more →GUTS▼ -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.
Read more →GUTSFractyl 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▲ +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 →GUTSFractyl 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 →GUTSFractyl 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.
Read more →GUTSFractyl Health to Report Third Quarter 2025 Financial Results and Provide Business Updates on November 12, 2025
Fractyl Health, a company specializing in metabolic therapeutics, will report its third quarter 2025 financial results on November 12, 2025. The announcement includes a live webcast for stakeholders to access the details. Fractyl aims to revolutionize treatment for obesity and type 2 diabetes with disease-modifying therapies.
Read more →GUTS▼ -6.8%on this news
Fractyl Health Announces Potent Preclinical Results from RJVA-002, a Dual GIP/GLP-1 Gene Therapy Candidate for Obesity
Fractyl Health announced promising preclinical results for RJVA-002, a dual GIP/GLP-1 gene therapy candidate targeting obesity. In a diet-induced obesity model, the therapy achieved approximately 30% weight loss in five weeks without adverse effects. This data supports the potential of RJVA-002 as a durable treatment option, expanding Fractyl's Rejuva platform's application beyond type 2 diabetes.
Read more →GUTS▲ +32.7%on this news· ran to +49% by day 1
Fractyl Health Announces Pricing of $60 Million Underwritten Offering of Common Stock
Fractyl Health has announced the pricing of an underwritten offering of 60 million shares at $1.00 each, aiming to raise approximately $60 million. The offering is set to close on or about September 29, 2025, pending customary conditions. BofA Securities and Evercore ISI are leading the offering, which follows a previously filed shelf registration with the SEC.
Read more →GUTS▲ +32.7%on this news· ran to +49% by day 1shared move
Fractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita® Maintained Weight Loss After GLP-1 Discontinuation
Fractyl Health announced promising results from the REMAIN-1 Midpoint Cohort study, demonstrating that patients treated with Revita maintained weight loss after stopping GLP-1 drugs. The study showed a statistically significant additional weight loss of 2.5% for Revita patients, while sham-treated patients regained 10%. This data supports Revita's potential as a first-in-class therapy for obesity management.
Read more →GUTSFractyl Health Expands Board of Directors with Appointments of Industry Leaders to Advance Clinical Execution and Strategic Growth
Fractyl Health has appointed Christopher Thompson, M.D. and Ian Sheffield to its Board of Directors to enhance clinical execution and strategic growth. These appointments come as the company advances its Revita product through late-stage development and prepares for the first-in-human study of its Rejuva gene therapy platform. The leadership changes aim to strengthen Fractyl's position in the metabolic therapeutics market.
Read more →GUTSFractyl Health Announces Second Quarter 2025 Financial Results and Business Updates Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025 Positive 3-month REVEAL-1 Cohort data showed single Revita p
Fractyl Health announced its second quarter 2025 financial results and highlighted progress in its Revita and Rejuva platforms. Positive results were reported from the REVEAL-1 Cohort, showing patients maintaining weight loss after discontinuing GLP-1 therapy. The company has completed a $23 million public offering to support upcoming data readouts and anticipates significant future data releases, including the REMAIN-1 Midpoint Cohort results due by September 2025. Additional studies and developments regarding the Rejuva gene therapy platform are also in progress.
Read more →GUTSFractyl Health Announces Closing of $23 Million Underwritten Public Offering Including Full Exercise of Underwriter’s Option to Purchase Additional Shares
Fractyl Health has successfully closed a $23 million underwritten public offering, which included the full exercise of the underwriter's option to purchase additional shares. The offering attracted significant participation from institutional investors and aims to extend the company's cash runway for upcoming clinical data readouts from its pivotal REMAIN-1 study. Proceeds will support the development of its Revita and Rejuva platforms.
Read more →GUTS▼ -46%on this newsshared move
Fractyl Health Announces Pricing of $20 Million Underwritten Public Offering
Fractyl Health has announced the pricing of a $20 million underwritten public offering, selling 19,047,619 shares of common stock along with Tranche A and B warrants. The proceeds will support its Revita and Rejuva pipeline programs. The offering is expected to close on August 7, 2025, subject to customary conditions.
Read more →GUTS▼ -46%on this newsshared move
Fractyl Health to Report Second Quarter 2025 Financial Results and Provide Business Updates on August 12, 2025, and Will Participate in an Upcoming Investor Conference
Fractyl Health, a metabolic therapeutics company, plans to report its second quarter 2025 financial results on August 12, 2025. The company will also provide business updates during this event. Following this, CEO Harith Rajagopalan will present at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025. Fractyl Health focuses on treating metabolic diseases like obesity and type 2 diabetes with innovative approaches.
Read more →GUTSFractyl Health Reports Potent and Durable Two-Year Real-World Outcomes with Revita Showing Sustained Weight Loss and Improved Glucose Control After a Single Procedure
Fractyl Health announced positive two-year follow-up results from the Germany Real-World Registry study, showcasing that a single Revita procedure led to a median weight loss of 9.6% and a 1.6% reduction in HbA1c levels in patients with type 2 diabetes. The outcomes remained stable throughout the two-year period, indicating the potential of Revita as a long-term, non-drug solution for metabolic control. The data align with previous clinical studies, contributing to expectations for the upcoming pivotal REMAIN-1 trial results. No serious adverse events related to the procedure have been reported.
Read more →GUTSFractyl Health Announces Proposed Public Offering
Fractyl Health, Inc. has announced its intent to conduct a public offering of common stock and pre-funded warrants to finance its pipeline programs for obesity and type 2 diabetes treatments. The underwriters are granted a 30-day option for additional shares. While the proceeds from the offering will support its innovative therapies, there are uncertainties related to market conditions and the regulatory landscape. Despite having a solid intellectual property portfolio, the company faces financial challenges and a lengthy approval process for its candidates.
Read more →GUTS▼ -24.8%on this news
Fractyl Health Presents New Data at the American Diabetes Association’s 85th Scientific Sessions Demonstrating its Rejuva Smart GLP-1™ Pancreatic Gene Therapy Platform Prevents Obesity and Type 2 Diabetes in Preclinical Models
Fractyl Health has announced promising new preclinical data for its Rejuva Smart GLP-1 pancreatic gene therapy platform, presented at the American Diabetes Association's 85th Scientific Sessions. The findings show that a single dose of Rejuva was well-tolerated in healthy mice and effectively prevented weight gain and hyperglycemia when exposed to a high-fat diet. The company is on track to move forward with its first clinical candidate, RJVA-001, targeting type 2 diabetes, with preliminary data expected by 2026. This research highlights the unique mechanism of action of Rejuva, distinguishing it from traditional systemic GLP-1 therapies.
Read more →GUTS▼ -24.8%on this news
Fractyl Health Reports Positive 3-Month REVEAL-1 Cohort Data Showing Revita Sustained Weight Loss After GLP-1 Discontinuation, Supporting its Potential as a First-in-Class Weight Maintenance Therapy 12 of 13 participants
Fractyl Health announced positive findings from the REVEAL-1 Cohort of its REMAIN-1 pivotal study, showing that 12 of 13 participants either maintained or lost weight after undergoing the Revita procedure following GLP-1 drug discontinuation. The study found that the median weight change was stable, contrasting with expected weight regain in such scenarios. Revita is noted for its excellent tolerance compared to GLP-1 drugs, with adverse effects reported as mild and transient. These results suggest a potential new approach to sustainable weight maintenance post-GLP-1 therapy.
Read more →GUTSFractyl Health Reinforces Intellectual Property Leadership in Metabolic Disease with Two New U.S. Patents Directed to Duodenal Resurfacing Robust intellectual property portfolio, built over more than a decade, designed t
Fractyl Health has announced the issuance of two new U.S. patents that bolster its intellectual property portfolio in the area of duodenal resurfacing. These patents are part of the company's strategy to secure its innovations aimed at treating metabolic diseases like obesity and type 2 diabetes. The patents include advancements in electrical energy applications for tissue ablation. As Fractyl prepares for important data readouts related to its lead product candidate, Revita, it aims to maintain its leadership in this emerging therapeutic space.
Read more →GUTS▼ -5.1%on this newsshared move
Fractyl Health to Present New Preclinical Data from its Rejuva Smart GLP-1™ Pancreatic Gene Therapy Platform at the American Diabetes Association's 85th Scientific Sessions
Fractyl Health, a metabolic therapeutics company, announced it will present new preclinical data from its Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Diabetes Association's 85th Scientific Sessions in Chicago. The presentation will focus on a study demonstrating that a single-dose GLP-1 based therapy can prevent obesity and diabetes in high-fat-fed mice. This innovative approach aims to provide disease-modifying treatments for obesity and type 2 diabetes.
Read more →GUTSFractyl Health and Bariendo Sign Letter of Intent to Prepare for Potential Offering of Revita Across its Bariatric and Metabolic Endoscopy Centers Nationwide
Fractyl Health and Bariendo have signed a non-binding Letter of Intent to collaborate on the potential launch of Fractyl's investigational Revita procedure, designed to help patients maintain weight after discontinuation of GLP-1 drugs. This partnership aims to provide an effective, scalable solution for obesity and metabolic disease through endoscopic procedures, pending FDA approval. Key clinical milestones related to the Revita procedure are expected in the next few years, focusing on establishing its efficacy and safety in the targeted population. With rising demand for alternatives to GLP-1 medications, this collaboration seeks to address critical unmet needs in obesity management.
Read more →GUTS▲ +25.4%on this news
Fractyl Health Advances Rejuva Gene Therapy Platform with Submission of First Clinical Trial Application Module in Europe for RJVA-001 in Type 2 Diabetes First-in-human study will evaluate safety, tolerability, and early
Fractyl Health has submitted the first module of its Clinical Trial Application for RJVA-001, a gene therapy aimed at treating type 2 diabetes through localized GLP-1 secretion. The phase 1/2 study will assess the safety, tolerability, and early efficacy of this innovative therapy, with the first patient doses expected in 2026, pending regulatory approval. The therapy utilizes an endoscopic method for direct pancreatic infusion, potentially offering a groundbreaking alternative to traditional diabetes management strategies.
Read more →GUTS▲ +25.4%on this newsshared move
Fractyl Health Unveils New Rejuva Smart GLP-1™ Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025
Fractyl Health presented promising preclinical data on its Rejuva Smart GLP-1 pancreatic gene therapy, RJVA-001, at ASGCT 2025. The therapy demonstrated durable metabolic improvements with targeted delivery and low systemic GLP-1 exposure in diabetic models, suggesting significant advantages over current GLP-1 drugs. The company aims to submit a Clinical Trial Application for RJVA-001 by June 2025, with human trials projected to begin in 2026. The findings were well-received, highlighting the potential of RJVA-001 to revolutionize treatment for obesity and type 2 diabetes.
Read more →GUTS▲ +25.4%on this newsshared move
Fractyl Health Unveils New Rejuva Smart GLP-1 TM Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025 Data suggests that single dose of RJVA-
Fractyl Health has presented new preclinical data for its Rejuva smart GLP-1 TM pancreatic gene therapy, RJVA-001, at the ASGCT 2025 Annual Meeting. The data highlights its capability to produce durable metabolic improvements with minimal systemic GLP-1 exposure, compared favorably with existing GLP-1 drugs. Key findings indicate that a single dose leads to significant reductions in fasting blood sugar and prevention of weight gain in diabetic models, supporting its use as a potential treatment that closely mimics natural hormone regulation. The company plans to advance towards human trials with the first Clinical Trial Application expected by June 2025.
Read more →GUTSFractyl Health Announces First Quarter 2025 Financial Results and Business Updates REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita's potential to maintain wei
Fractyl Health has announced its first-quarter 2025 financial results and significant business updates highlighting progress in its metabolic therapeutics initiatives. The company is set to provide data from its REVEAL-1 and REMAIN-1 cohorts, demonstrating early signs of weight maintenance efficacy for its treatment Revita following GLP-1 cessation. Enrollment for the REMAIN-1 Pivotal Cohort has been completed ahead of schedule, with crucial data expected in upcoming quarters. Despite financial losses reported for this quarter, Fractyl is advancing its gene therapy initiative Rejuva, aimed at treating Type 2 diabetes.
Read more →GUTS▼ -8%on this news
Fractyl Health to Report First Quarter 2025 Financial Results and Provide Business Updates on May 13, 2025, and Will Participate in an Upcoming Investor Conference
Fractyl Health, Inc. (Nasdaq: GUTS) announced its plans to report financial results for the first quarter of 2025 and provide business updates on May 13, 2025. The company will also be participating in the BofA Securities 2025 Health Care Conference on May 14, 2025, where CEO Harith Rajagopalan will present. Both events will be accessible via webcasts, which will be archived for later access. Fractyl focuses on treating the root causes of obesity and type 2 diabetes.
Read more →GUTSFractyl Health to Present Compelling Preclinical Data from its Rejuva Single-Administration Smart GLP-1 Pancreatic Gene Therapy Platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting
Fractyl Health, a company focused on metabolic therapeutics, will present noteworthy preclinical data on its Rejuva gene therapy platform at the ASGCT 2025 Annual Meeting. The oral presentation will discuss the safety and feasibility of a pancreatic gene therapy approach using endoscopic ultrasound-guided delivery. The data showcases advancements in treating the root causes of obesity and type 2 diabetes. The company aims to submit a Clinical Trial Application for its gene therapy in early 2025, expecting to provide initial results by 2026.
Read more →GUTS▼ -6.7%on this news
Fractyl Health Reports Positive Early Data Showing Revita Has Potential to Prevent Weight Regain After GLP-1 Discontinuation New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation R
Fractyl Health announced promising early results from its REVEAL-1 study, indicating that its Revita treatment may help prevent weight regain after patients cease using GLP-1 drugs. The study observed 15 patients, noting an average weight regain of just 1.2% after one month compared to the typical 3% expected during this timeframe. With no safety concerns reported, the findings portray Revita as a favorable option for long-term weight maintenance. The company anticipates further data milestones in 2025, including additional follow-up results and full study enrollment.
Read more →GUTSFractyl Health Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates Strong patient and physician demand for pivotal REMAIN-1 study highlights urgent need for post-GLP-1 withdrawal weight mai
Fractyl Health (GUTS) announced its fourth quarter and full year 2024 financial results, showcasing strong progress in its pivotal REMAIN-1 study aimed at long-term weight maintenance post-GLP-1 therapy. The company reported significant enrollment figures and expressed optimism about key upcoming clinical milestones in 2025, including the submission of a Clinical Trial Application for RJVA-001 targeted at type 2 diabetes. Despite a net loss of $25 million, Fractyl remains focused on its revolutionary approach to obesity treatment, indicating a strategic pivot towards their most pressing research needs.
Read more →GUTSFractyl Health to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 3, 2025
Fractyl Health, Inc. (NASDAQ: GUTS) will report its financial results for the fourth quarter and full year 2024 on March 3, 2025, at 4:30 p.m. ET. The company, based in Burlington, MA, specializes in metabolic therapeutics, particularly for obesity and type 2 diabetes. Alongside the financial update, Fractyl plans to provide business updates during the conference call. Interested parties can access a live webcast through the company's website.
Read more →GUTS▼ -5.2%on this news· ran to -15% by day 3
Fractyl Health Announces Increased Focus on Groundbreaking Revita Weight Maintenance and Rejuva Pancreatic Gene Therapy Programs with Potential to Deliver Key Clinical Milestones Across Multiple Studies in 2025 Prioritiz
Fractyl Health has announced a strategic focus on its Revita weight maintenance and Rejuva gene therapy programs in response to patient demand. The company is emphasizing the REMAIN-1 pivotal study, with positive preliminary results already reported, and plans to pause investments in certain T2D programs. They aim to initiate first-in-human studies for their gene therapy candidate RJVA-001 in early 2025. These adjustments are designed to extend the company's cash runway through 2026 while meeting urgent patient needs.
Read more →GUTS▲ +5.4%on this news
Fractyl Health Announces Positive Initial Clinical Results Demonstrating Weight Maintenance Following GLP-1 Discontinuation and Revita Procedure in First Patient of the REVEAL-1 Cohort Company also announces strong enrol
Fractyl Health has reported initial positive clinical results from the REVEAL-1 cohort, demonstrating that patients maintained weight after discontinuing GLP-1 treatment and undergoing the Revita procedure. The company also highlighted successful enrollment for its pivotal REMAIN-1 study, emphasizing significant interest from both patients and healthcare professionals. These developments signal a potential shift in addressing long-term weight maintenance for those stopping GLP-1 therapy. Results from REVEAL-1 are set to be presented in Q1 2025, with a mid-point analysis for REMAIN-1 expected in Q2 2025.
Read more →GUTSFractyl Health Unveils Promising Preclinical Data Demonstrating Safety and Feasibility of Local Delivery of RJVA-001 Rejuva Smart GLP-1™ Pancreatic Gene Therapy at the World Congress Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC)
Fractyl Health has presented promising preclinical data on its RJVA-001 pancreatic gene therapy, which demonstrates safety and feasibility through local delivery methods in Yucatan pig models. The study confirmed effective targeting of the pancreas and achieved significant GLP-1 expression without adverse effects. The company plans to initiate first-in-human studies in the first half of 2025, aiming to address critical needs in obesity and type 2 diabetes treatment. The findings were shared at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease (WCIRDC).
Read more →GUTSFractyl Health to Present New Preclinical Data from its Rejuva Single-Administration Smart GLP-1 Pancreatic Gene Therapy Platform at the World Congress Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC)
Fractyl Health, Inc. (Nasdaq: GUTS) is set to present new preclinical data from its Rejuva platform at the upcoming 2024 World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. The session will showcase a poster titled 'Feasibility and Safety of Novel Endoscopic Ultrasound-Guided Delivery of Human GLP-1 Pancreatic Gene Therapy in Pigs'. The company focuses on innovative treatments for obesity and Type 2 Diabetes, aiming to shift from chronic management to disease-modifying therapies.
Read more →GUTSFractyl Health to Participate in the Upcoming December Conferences
Fractyl Health, a company specializing in metabolic therapeutics, has announced its participation in two upcoming investor conferences. The presentations will feature Harith Rajagopalan, the CEO, discussing the company's innovative approaches to treat obesity and Type 2 Diabetes. The events highlight Fractyl's commitment to changing the landscape of metabolic disease treatment. Webcast replays of the conferences will be available on the company's website following the live sessions.
Read more →GUTSFractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates REMAIN-1 weight maintenance pivotal study enrollment progressing rapidly; mid-point data analysis expected in Q2 2025 Anticipate r
Fractyl Health reported its third quarter 2024 financial results, highlighting rapid enrollment in the REMAIN-1 pivotal study, with mid-point data analysis expected in Q2 2025. The company anticipates sharing data from the REVEAL-1 cohort starting Q4 2024. Additionally, Fractyl discussed promising results from recent presentations at ObesityWeek 2024 and introduced a new gene therapy candidate aimed at obesity treatment. However, the company also noted a significant increase in net loss and research expenses compared to the previous year.
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About Rejuva Fractyl Health's Rejuva  platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform i
Fractyl Health is set to present promising preclinical data on its RJVA-001 gene therapy for weight maintenance and blood sugar control at ObesityWeek 2024. The findings indicate sustained effects in diet-induced obesity models over a 13-week period, making it the longest efficacy demonstration for this therapy to date. Additionally, the company has nominated RJVA-002 as its first dual agonist candidate for obesity treatment. These developments position Fractyl Health at the forefront of innovation in metabolic disease therapies.
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Fractyl Health to Present New Preclinical Data on Sustained Weight Maintenance and Blood Sugar from its Rejuva RJVA-001 Single-Administration GLP-1 Pancreatic Gene Therapy Candidate at ObesityWeek 2024
Fractyl Health will present promising new preclinical data on RJVA-001, a single-administration GLP-1 pancreatic gene therapy candidate, at ObesityWeek 2024. The data indicate sustained weight maintenance and improved blood sugar control in a diet-induced obesity mouse model, representing a significant advancement in the treatment of obesity and Type 2 Diabetes. The company also announced the nomination of RJVA-002, a dual GIP/GLP-1 agonist, indicating ongoing development in their pancreatic gene therapy pipeline.
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Fractyl Health Presented New Analysis from Pooled Data of Revita Clinical Studies Demonstrating Durable Weight Loss Maintenance for One Year at ObesityWeek 2024
Fractyl Health presented new data from pooled studies on its Revita procedure at ObesityWeek 2024, showing significant and sustained weight loss in patients with Type 2 Diabetes after one month, with the majority maintaining this loss for up to one year. The outcomes suggest the procedure could outperform existing obesity drugs by providing a durable solution without ongoing lifestyle changes. Revita's FDA Breakthrough Device designation reflects its potential to address unmet needs in obesity treatment. Upcoming data reports from additional studies are anticipated in Q4 2024 and Q2 2025.
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Fractyl Health to Report Third Quarter 2024 Financial Results and Provide Business Updates on November 12, 2024
Fractyl Health, Inc. (Nasdaq: GUTS) has announced that it will report its financial results for the third quarter of 2024 on November 12 at 4:30 p.m. ET. Along with the financial results, the company will provide business updates during a conference call. Fractyl Health specializes in metabolic therapeutics aimed at addressing obesity and Type 2 diabetes through innovative approaches. A live webcast of the call will be available on the company's website, and it will be archived for later access.
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Fractyl Health to Present Compelling Weight Maintenance Data from both Revita and Rejuva Platforms at ObesityWeek 2024
Fractyl Health, a metabolic therapeutics company, will showcase significant data on weight maintenance from its Revita and Rejuva platforms at ObesityWeek 2024 in San Antonio, Texas. The presentations will occur between November 3-5, 2024, highlighting the potential of their therapies in treating obesity and Type 2 Diabetes. Revita, in particular, has received recognition from regulatory bodies, showing promise in metabolic disease management.
Read more →GUTSFractyl Health to Present at Chardan’s 8th Annual Genetic Medicines Conference
Fractyl Health, Inc. (Nasdaq: GUTS) will present at Chardan's 8th Annual Genetic Medicines Conference on October 1, 2024. Harith Rajagopalan, M.D., Ph.D., the CEO, will participate in a fireside chat to discuss the company's pioneering approaches to metabolic diseases. Fractyl focuses on addressing root causes of obesity and Type 2 Diabetes, challenging the current paradigm of symptomatic management. A webcast replay of the session will be available on the company's website following the live presentation.
Read more →GUTSFractyl Health to Participate in Upcoming September Investor Conferences
Fractyl Health, Inc. has announced that its CEO, Harith Rajagopalan, will present at two significant investor conferences this September. The company focuses on treating the root causes of obesity and Type 2 Diabetes through innovative therapeutic approaches. Live presentations will be followed by webcasts accessible on the company's investor relations webpage, highlighting their commitment to transparency and shareholder engagement. Fractyl Health aims to shift the treatment paradigm for metabolic diseases towards disease-modifying therapies.
Read more →GUTSFractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates Updated clinical results from German Real-World Registry demonstrate potential for Revita to meaningfully sustain weight loss and
Fractyl Health has reported its second-quarter financial results for 2024, emphasizing the potential benefits of its Revita treatment for sustained weight loss and blood sugar control post-therapy. The company received FDA Breakthrough Device designation for Revita, facilitating a faster regulatory review process. Clinical updates indicate significant weight loss among patients in a German registry following treatment with Revita. Additionally, Fractyl is advancing its Rejuva pancreatic gene therapy program, showing promise in preclinical studies.
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Fractyl Health Announces Clinical Results from German Real-World Registry Showing Meaningful and Sustained Weight Loss for at Least One Year After a Single Revita Endoscopic Procedure
Fractyl Health has announced promising results from its German Real-World Registry, demonstrating that the Revita endoscopic procedure led to significant and sustained weight loss for at least one year in a cohort of patients with obesity and Type 2 Diabetes. The median weight reduction was nearly 13%, and median HbA1c levels decreased from 9.6% to 7.2%. Patients experienced maintained or reduced levels of glucose-lowering medications after the intervention. Further data from a larger patient population will be presented at an upcoming scientific congress.
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Fractyl Health to Report Second Quarter 2024 Financial Results and Provide Business Updates on August 14, 2024
Fractyl Health, Inc. (Nasdaq: GUTS) will announce its second quarter 2024 financial results and provide business updates on August 14, 2024, at 4:30 p.m. ET. The company, based in Burlington, Massachusetts, focuses on innovative approaches to treat obesity and type 2 diabetes. A live webcast of the conference call will be available on Fractyl's website, and the event will be archived for later access.
Read more →GUTSFractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People wi th Obesity Who Discontinue GLP-1 Based Drugs Breakthrough Device Designations are granted by the U.S. FDA to expe
Fractyl Health has announced that the FDA has granted Breakthrough Device Designation for its Revita System, aimed at maintaining weight loss for patients discontinuing GLP-1 drugs. This designation promises expedited regulatory review and potential reimbursement support. Revita is an endoscopic procedure targeting the duodenal lining to improve metabolism and glucose regulation. The REMAIN-1 pivotal study is currently underway, with interim data expected to begin in Q4 2024.
Read more →GUTS▼ -9.2%on this news
Fractyl Health to Present at Piper Sandler 2nd Annual Virtual Obesity Day
Fractyl Health, Inc. announced that its CEO and CSO will participate in the Piper Sandler 2nd Annual Virtual Obesity Day, discussing the company's advancements in treating obesity and type 2 diabetes. The firm revealed promising preclinical data from its GLP-1 pancreatic gene therapy, Rejuva, which demonstrated greater and more durable weight loss compared to semaglutide. Fractyl's innovative approaches aim to provide durable disease-modifying therapies, addressing metabolic diseases' root causes. The event highlights the company's commitment to transforming treatment methodologies in its field.
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Fractyl Health Announces Advancement in Weight Maintenance Pipeline and Business Updates Company will accelerate Revita weight maintenance clinical study REMAIN-1; open label data from REVEAL-1 cohort expected in Q4 2024
Fractyl Health has announced advancements in its clinical programs, including the acceleration of the REMAIN-1 study for its Revita device, which focuses on weight maintenance post-GLP-1 therapy. The company is also expanding the REVITALIZE-1 study's patient eligibility, significantly increasing the U.S. treatment population for diabetes. Furthermore, promising preclinical data comparing the Rejuva gene therapy to semaglutide suggest improved weight loss outcomes. Open label data from the REMAIN-1 cohort is expected by Q4 2024, with pivotal results anticipated in mid-2025.
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Fractyl Health Presents New Preclinical Data on Sustained Weight Maintenance and Improved Body Composition from its Rejuva Single-Administration GLP-1 Pancreatic Gene Therapy in President’s Select Oral Presentation at the American Diabetes Association’s 84th Scientific Sessions
Fractyl Health presented promising preclinical data on its Rejuva pancreatic gene therapy at the ADA's 84th Scientific Sessions. The data indicated that a single administration of Rejuva significantly reduced fat mass and improved glycemia in a diet-induced obesity mouse model. Furthermore, Rejuva maintained these benefits even after the withdrawal of semaglutide, presenting itself as a potential off-ramp from chronic GLP-1 treatments. This research positions Rejuva as a significant advancement in managing obesity and type 2 diabetes.
Read more →GUTSFractyl Health to Present New Preclinical Obesity Data from Rejuva Platform at the American Diabetes Association’s 84th Scientific Sessions
Fractyl Health, a company focused on metabolic therapeutics, will present new preclinical data from its Rejuva platform at the American Diabetes Association's 84th Scientific Sessions in June 2024. The study, recognized as a noteworthy abstract, explores the efficacy of GLP-1-based pancreatic gene therapy in maintaining body composition and glycemia in a murine model following Semaglutide withdrawal. Additionally, Fractyl will host a Key Opinion Leader event involving discussions on the treatment landscape for obesity and type 2 diabetes, featuring expert insights.
Read more →GUTSFractyl Health Presents Compelling Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva at Digestive Disease Week 2024
Fractyl Health presented promising preclinical data for its GLP-1 pancreatic gene therapy, Rejuva, at Digestive Disease Week 2024. The therapy demonstrated significant reductions in liver weight and triglycerides, indicating its potential for treating metabolic conditions. CEO Harith Rajagopalan highlighted the durability and impact of this therapy, which could offer curative options for liver diseases associated with obesity. The company plans to nominate the therapy's first candidate for obesity treatment in the latter half of 2024.
Read more →GUTSFractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates Initiation of Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 based drugs ex
Fractyl Health reported its first quarter 2024 financial results, showcasing business advancements and upcoming clinical studies. The company plans to initiate its pivotal Remain-1 study for weight maintenance and anticipates topline data from the Revitalize-1 study for T2D patients in late 2024. Fractyl also announced the introduction of a new Chief Commercial Officer, Adrian Kimber, and detailed current research efforts and financial metrics. Despite showing revenue stability, rising expenses led to a net loss, highlighting financial challenges as the company progresses.
Read more →GUTSFractyl Health Presents Clinical Update on Revita German Real-World Registry for Patients With Advanced Type 2 Diabetes (T2D)
Fractyl Health has presented promising 6-month follow-up data from its German real-world registry study of Revita for patients with advanced Type 2 Diabetes (T2D). The initial 14 participants showed significant improvements in blood glucose, with median HbA1c levels dropping from 9.2% to 7.6% and an average weight loss of 8.1%. Importantly, no serious adverse events have been reported related to the procedure, indicating a favorable safety profile as the study progresses.
Read more →GUTSFractyl Health to Present at BofA Securities 2024 Health Care Conference
Fractyl Health, a company specializing in metabolic therapeutics, has announced that CEO Dr. Harith Rajagopalan will present at the BofA Securities 2024 Health Care Conference on May 15, 2024. The conference will feature a fireside chat format, enabling insights into Fractyl's innovative strategies to address obesity and type 2 diabetes. The company aims to shift from traditional symptomatic management to more effective disease-modifying therapies.
Read more →GUTSFractyl Health to Report First Quarter 2024 Financial Results and Provide Business Updates on May 13, 2024
Fractyl Health, Inc. (Nasdaq: GUTS) has announced that it will release its financial results for the first quarter of 2024 on May 13, 2024. Following the announcement, the company's management will host a conference call at 4:30 p.m. ET to discuss the results and provide additional business updates. The live webcast of the call will be available on the Fractyl Health website, with options for replay post-event.
Read more →GUTSFractyl Health Announces Multiple Presentations at the Upcoming Digestive Disease Week (DDW) 2024 Conference and the German Diabetes Association (DDG) Annual Meeting
Fractyl Health has announced its participation in two major conferences, presenting new clinical data on its treatments for type 2 diabetes and obesity. At the German Diabetes Association Annual Meeting, the company will share results from an ongoing registry study on its Revita treatment. Additionally, at Digestive Disease Week, they will present new preclinical findings concerning the Rejuva platform, which explores gene therapy's effects on liver health. These presentations highlight Fractyl's ongoing commitment to address metabolic diseases through innovative therapies.
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Fractyl Health Expands Leadership with Appointment of Adrian Kimber as Chief Commercial Officer to Spearhead Anticipated Launch Preparation as the Company Conducts Two Pivotal Studies for Revita in Obesity and Type 2 Diabetes
Fractyl Health has appointed Adrian Kimber as Chief Commercial Officer to lead the company's preparation for the upcoming launch of the Revita system, aimed at treating obesity and type 2 diabetes. Kimber brings over 20 years of expertise from reputable biotechnology and medical device companies, which is expected to be instrumental in the commercialization of Revita. The company is conducting two pivotal studies for its lead product candidate, Revita, which targets metabolic diseases through innovative mechanisms. This hiring aligns with Fractyl's strategic focus on transforming treatment paradigms in obesity and diabetes care.
Read more →GUTSFractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Received IDE approval for the Revita Remain-1 pivotal study for weight maintenance in patients with obesity after di
Fractyl Health has reported its fourth quarter and full year 2023 financial results, highlighting significant achievements such as IDE approval for the Remain-1 pivotal study targeting weight maintenance in patients with obesity. The company anticipates completing enrollment in the Revitalize-1 study and releasing topline data in late 2024. They also announced the first candidate from their Rejuva GLP-1 gene therapy platform, RJVA-001, with IND-enabling studies expected to be completed in the latter half of 2024. Additionally, Fractyl's recent IPO raised $110 million to fund ongoing operations through 2025.
Read more →GUTSFractyl Health Receives FDA IDE Approval for the Revita Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs Revita aims to be the first approved therapeutic option for durab
Fractyl Health received FDA IDE approval for its Revita Remain-1 pivotal study, which focuses on weight maintenance in obese individuals after GLP-1 receptor agonist discontinuation. This study aims to potentially establish Revita as the first approved therapeutic option for durable weight maintenance. The Remain-1 study will include a randomized, double-blind trial of Revita versus sham treatment, involving at least 315 participants who have lost significant weight with prior GLP-1RA therapy. Additionally, an open-label cohort, Reveal-1, will monitor similar patients throughout the study.
Read more →GUTS▼ -10.3%on this news
Fractyl Health Announces New Results From Its Rejuva Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity
Fractyl Health has unveiled new preclinical results for its RJVA-001 pancreatic gene therapy, which showcases potent effects on glucose lowering and weight reduction in db/db mice. In comparison to chronic semaglutide treatment, RJVA-001 led to a more significant decrease in blood sugar and body weight. As the company progresses toward IND enablement and clinical trials, it has aligned with European regulators on using this animal model for its Clinical Trial Application. However, both financial and regulatory challenges remain significant factors for ensuring successful advancement of this therapeutic approach.
Read more →GUTSFractyl Health Appoints Samuel Conaway to Its Board of Directors, Bolstering New Product Commercial Expertise During Revita Pivotal Clinical Trials
Fractyl Health has appointed Samuel Conaway to its Board of Directors, enhancing its commercial expertise as it progresses through pivotal clinical trials for its lead product candidate, Revita. Conaway brings a wealth of experience in the commercialization of medical technologies, which is expected to benefit the company as it seeks to launch new treatment options for Type 2 Diabetes and obesity. His strategic vision is anticipated to support Fractyl Health in achieving its clinical milestones, reinforcing its commitment to innovative therapies in metabolic disease treatment.
Read more →GUTSFractyl Health Announces Pricing of Initial Public Offering
Fractyl Health has announced the pricing of its initial public offering, offering 7,333,333 shares at $15.00 each, slated to raise around $110 million. The IPO is expected to close on February 6, 2024, with trading on the Nasdaq beginning on February 2, 2024, under the ticker symbol 'GUTS.' The offering includes a 30-day option for underwriters to purchase additional shares. This move positions Fractyl Health to advance its mission of treating metabolic diseases, notably type 2 diabetes and obesity.
Read more →GUTSFractyl Health Announces Nomination of RJVA-001 as First Clinical Candidate in Its Rejuva GLP-1 Gene Therapy Platform
Fractyl Health has announced the nomination of RJVA-001 as its first clinical candidate in its Rejuva GLP-1 gene therapy platform, aimed at treating Type 2 Diabetes (T2D) and obesity. This candidate is designed to address common issues such as treatment discontinuation and metabolic rebound associated with existing therapies. Furthermore, Fractyl has successfully engaged with European regulators to facilitate the clinical trial process, with the expectation of completing IND-enabling studies in the second half of 2024. The Rejuva platform could potentially transform metabolic disease treatment by offering localized genetic therapies that promote long-term hormone production in the pancreas.
Read more →GUTSFractyl Health Announces New Pooled Analysis From Revita Clinical Studies Demonstrating Initial Weight Loss and Sustained Weight Maintenance Without Weight Regain Through at Least One Year Post-Revita Procedure
Fractyl Health announced promising results from a pooled analysis of Revita clinical studies. The findings indicate that a single Revita endoscopic procedure resulted in an initial average weight loss of 3.4% by Week 4, which increased to a sustained 4% by Week 48 in patients with advanced type 2 diabetes. These results were statistically significant and suggest the potential of Revita to prevent weight regain after weight loss. Fractyl plans to submit an Investigational Device Exemption in early 2024 to facilitate a larger clinical study focusing on weight maintenance after the cessation of GLP-1 therapies.
Read more →GUTSFractyl Health Demonstrated That a Single Dose of a GLP-1-Based Pancreatic Gene Therapy Candidate (GLP-1 PGTx) Durably Maintained Weight Loss After Semaglutide Withdrawal in a Murine Model of Obesity at WCIRDC 2023 Annual Meeting
Fractyl Health revealed promising preclinical findings from their GLP-1 PGTx pancreatic gene therapy, demonstrating substantial and sustained weight loss in a rodent model of obesity. The therapy resulted in 27% weight loss after a single dose, compared to 21% with chronic semaglutide treatment. Moreover, those who transitioned from semaglutide to GLP-1 PGTx maintained their weight loss, hinting at the therapy's durability. The company plans to move GLP-1 PGTx forward into further studies in 2024, targeting obesity and type 2 diabetes treatment.
Read more →GUTSFractyl Health Expands Landmark Academic-Industry Collaboration to Study Mechanisms Underlying GLP-1-Based Pancreatic Gene Therapy for Type 2 Diabetes and Obesity
Fractyl Health has announced the expansion of an academic-industry collaboration with Professor Randy Seeley of Michigan Medicine to explore pancreatic gene therapy's role in treating type 2 diabetes and obesity. This initiative, part of the ERASE Task Force, aims to investigate how targeted gene therapy can change the treatment landscape for these chronic diseases. The collaboration underscores a potential shift from chronic management to durable solutions in metabolic disease therapy.
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