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Fractyl Health, Inc. (GUTS)

1.9000

0.0000

(0.00%)

As of 1:24:15 PM EDT. Market Open.

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 efficacy of a one-time, pancreas-targeted smart GLP-1TM gene therapy for patients with inadequately controlled T2D and obesity Expect to dose first patients and report preliminary data in 2026, pending CTA authorization BURLINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company pioneering pattern-breaking treatments for obesity and type 2 diabetes (T2D),

GlobeNewswire 14 days ago

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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

Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs Endoscopic ultrasound-guided delivery achieves targeted pancreatic expression in a large animal model with no toxicity observed to date Data show nutrient-responsive GLP-1 secretion in human beta cells and human islets, demonstrating th

GlobeNewswire 16 days ago

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Fractyl 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 weight loss after GLP-1 discontinuation in the real world REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 2026 Rejuva gene therapy platform advancing toward first-in-human studies; first CTA m

GlobeNewswire 19 days ago

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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

BURLINGTON, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the first quarter 2025 and provide business updates on Tuesday, May 13, 2025, at 4:30 p.m. ET. A live webcast of the conference call can be accessed in the “Events” section of Fractyl Health’s website at http:

GlobeNewswire 27 days ago

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Fractyl 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

BURLINGTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced that it will deliver an oral presentation of 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, taking p

GlobeNewswire last month

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Discover Fractyl Health And 2 More Promising Penny Stocks

Over the last 7 days, the United States market has dropped 4.4%, yet earnings are forecast to grow by 13% annually. For those looking to invest in smaller or newer companies, penny stocks can still offer surprising value despite their somewhat outdated name. With solid financial foundations, these stocks have the potential to outperform while offering greater stability, making them intriguing options for investors seeking under-the-radar opportunities with long-term potential.

Simply Wall St. last month

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TSHA

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Fractyl Health, Inc. (GUTS): Insider Were Buying In Q1 2025

We recently published a list of 10 Micro-Cap Stocks Insiders Were Buying In Q1 2025. In this article, we are going to take a look at where Fractyl Health, Inc. (NASDAQ:GUTS) stands against other micro-cap stocks insiders were buying in Q1 2025. The White House announced Tuesday that Trump’s tariffs would take effect immediately after […]

Insider Monkey last month

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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 REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data from the open-label REVEAL-1 coho

GlobeNewswire 2 months ago

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Spotlight On Fractyl Health And Two Other Intriguing Penny Stocks

As the U.S. stock market grapples with the impact of new tariffs and economic uncertainties, investors are increasingly looking for opportunities beyond well-known names. Penny stocks, a term that might seem outdated, still hold relevance as they often represent smaller or newer companies with potential for growth at lower price points. In this article, we explore three intriguing penny stocks that stand out for their financial strength and offer promising opportunities for those seeking...

Simply Wall St. 2 months ago

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Fractyl 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 maintenance solutions; midpoint data analysis anticipated in Q2 2025 and full study enrollment expected in summer 2025 Company plans to submit first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if CTA is authorized, expects to report preliminary data in 2026 Conference call today at 4:30 p.m. ET BURLINGTON, Mass., March 03

GlobeNewswire 2 months ago

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Fractyl Health to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 3, 2025

BURLINGTON, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), today announced it will report financial results for the fourth quarter and full year 2024 and provide business updates on Monday, March 3, 2025, at 4:30 p.m. ET. A live webcast of the conference call can be accessed in the “Events” section of Fractyl’s w

GlobeNewswire 3 months ago

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After Plunging -19.55% in 4 Weeks, Here's Why the Trend Might Reverse for Fractyl Health, Inc. (GUTS)

Fractyl Health, Inc. (GUTS) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

Zacks 3 months ago

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Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments

Fractyl Health is entering pivotal studies for a procedure that aims to be an ‘off ramp’ to GLP-1s and exploring how a one-time, ‘smart GLP-1’ gene therapy can Treat type 2 diabetes.

Pharma Voice 3 months ago

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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

Prioritizing Revita’s clinical development on weight maintenance post-GLP-1 withdrawal in response to significant patient and physician demand in ongoing REMAIN-1 pivotal study; anticipate midpoint data analysis in Q2 2025 and full pivotal study enrollment in summer 2025 RJVA-001, first clinical candidate in Rejuva gene therapy program, has completed key preclinical in vivo studies; on-track to initiate first-in-human studies in H1 2025 Streamlined focus expected to extend cash runway into 2026

GlobeNewswire 3 months ago

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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 enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 dia

GlobeNewswire 4 months ago

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Here’s Why Fractyl Health, Inc. (NASDAQ:GUTS) Is Among the Best Diabetes Stocks to Buy Under $10

We recently compiled a list of the 10 Best Diabetes Stocks To Buy Under $10. In this article, we are going to take a look at where Fractyl Health, Inc. (NASDAQ:GUTS) stands against the other diabetes stocks. Global Growth and Innovation in Diabetes Care: The Rise of Continuous Glucose Monitors and AI Integration About 422 million […]

Insider Monkey 4 months ago

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Fractyl 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)

RJVA-001 was successfully delivered in large animal Yucatan pig models at low total viral dose Results confirm ability to directly target pancreas with novel delivery catheter and route of administration Local delivery of RJVA-001 achieved therapeutically relevant GLP-1 expression within pancreatic beta cells with no adverse safety effects observed Company plans to initiate first-in-human studies with RJVA-001 in first half of 2025 BURLINGTON, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Fractyl Hea

GlobeNewswire 5 months ago

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Fractyl 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)

BURLINGTON, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced it will present new preclinical data from its Rejuva platform at the 2024 Poster Session of the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place December 12-14, 2024. Details of the session are below:

GlobeNewswire 5 months ago

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Fractyl Health to Participate in the Upcoming December Conferences

BURLINGTON, Mass., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will present at two upcoming investor conferences. Details of the presentations can be found below. 7th Annual Evercore ISI HealthCONx Conference Format:

GlobeNewswire 6 months ago

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Fractyl Health Third Quarter 2024 Earnings: US$0.48 loss per share (vs US$9.61 loss in 3Q 2023)

Fractyl Health ( NASDAQ:GUTS ) Third Quarter 2024 Results Key Financial Results Net loss: US$23.2m (loss widened by 15...

Simply Wall St. 6 months ago

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Performance Overview

Return	GUTS	S&P 500 (^GSPC)
YTD	-7.77%	+0.50%
1-Year	-71.81%	+12.01%
3-Year	-86.18%	+41.52%

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Fractyl Health, Inc. (GUTS)

Fractyl Health Advances Rejuva® Gene Therapy Platform with Submission of First Clinical Trial Application Module in Europe for RJVA-001 in Type 2 Diabetes

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 Announces First Quarter 2025 Financial Results and Business Updates

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 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

Discover Fractyl Health And 2 More Promising Penny Stocks

Fractyl Health, Inc. (GUTS): Insider Were Buying In Q1 2025

Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation

Spotlight On Fractyl Health And Two Other Intriguing Penny Stocks

Fractyl Health Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates

Fractyl Health to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 3, 2025

After Plunging -19.55% in 4 Weeks, Here's Why the Trend Might Reverse for Fractyl Health, Inc. (GUTS)

Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments

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

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

Here’s Why Fractyl Health, Inc. (NASDAQ:GUTS) Is Among the Best Diabetes Stocks to Buy Under $10

Fractyl 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 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 to Participate in the Upcoming December Conferences

Fractyl Health Third Quarter 2024 Earnings: US$0.48 loss per share (vs US$9.61 loss in 3Q 2023)

Performance Overview