Fractyl Health Presents Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva at Digestive Disease Week 2024

5/20/24 6:04:23 AM ET

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Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), presented new data from its preclinical Rejuva pancreatic gene therapy program as part of an oral presentation (abstract number 4029196) on Sunday, May 19th, at Digestive Disease Week (DDW) 2024 in Washington, D.C.

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Date	Price Target	Rating	Analyst
2/28/2024		Outperform	Evercore ISI
2/27/2024	$18.00	Overweight	Morgan Stanley
2/27/2024	$26.00	Buy	BofA Securities

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Fractyl Health Accelerates Key Clinical Trials for Obesity and Diabetes Treatments
Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that it will accelerate its REMAIN-1 clinical study, which is evaluating Revita's efficacy in maintaining weight loss following the discontinuation of GLP-1 therapy. The Company also announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol for the REVITALIZE-1 study of its Revita device, which expands eligibility to patients with T2D who are inadequately controlled on any glucose lowering agent, including GLP-1 agonists and/or insulin, thus expanding
6/24/24 6:07:35 AM ET
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Reported Earlier, Fractyl Health Unveils Preclinical Data on Obesity and Diabetes Gene Therapy
Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)'s 84th Scientific Sessions in Orlando, FL. The presentation titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity," and was chosen as noteworthy and one of eight President's Select Abstracts at ADA this year. Rejuva is the Company's adeno-associated virus (AAV)
6/24/24 3:12:36 AM ET
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Fractyl Health Announced Single Administration Of Rejuva Reduced Fat Mass And Improved Glycemia In The Well-validated Diet-induced Obesity Mouse Model
Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)'s 84th Scientific Sessions in Orlando, FL. The presentation titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity," and was chosen as noteworthy and one of eight President's Select Abstracts at ADA this year. Single administration of Rejuva reduced fat mass and
6/23/24 2:35:32 PM ET
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Fractyl 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 reporting data from REVEAL-1 open-label cohort beginning in Q4 2024 Topline data from REVITALIZE-1 pivotal study expected in mid-2025 Company presented compelling weight maintenance data from both Revita® and Rejuva® platforms at ObesityWeek® 2024 Conference call today at 4:30 p.m. ET BURLINGTON, Mass, Nov. 12, 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 reported its third quarter 2024 finan
11/12/24 4:05:42 PM ET
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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
13-week follow-up represents the longest data to-date demonstrating durable efficacy of RJVA-001 on weight and blood sugar in the diet-induced obesity (DIO) mouse model Company plans to use durable efficacy results as part of its FIH data package for RJVA-001 Fractyl also announces the nomination of RJVA-002, a GIP/GLP-1 dual agonist, as its first pancreatic gene therapy candidate for obesity BURLINGTON, Mass., Nov. 04, 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), will present new preclinical data on sustained weight mainten
11/4/24 4:05:00 PM ET
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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
Single Revita procedure led to sustained, clinically meaningful weight loss in majority of patients with Type 2 Diabetes REMAIN-1 weight maintenance pivotal study on-track to report mid-point data analysis in Q2 2025 Company will report weight maintenance data after discontinuation of GLP-1 drugs in open-label REVEAL-1 cohort in Q4 2024 BURLINGTON, Mass., Nov. 04, 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), presented the poster, "Duodenal Mucosal Resurfacing (DMR) Durably Maintains Weight Loss in Metabolic D
11/4/24 7:00:00 AM ET
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Fractyl 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 reporting data from REVEAL-1 open-label cohort beginning in Q4 2024 Topline data from REVITALIZE-1 pivotal study expected in mid-2025 Company presented compelling weight maintenance data from both Revita® and Rejuva® platforms at ObesityWeek® 2024 Conference call today at 4:30 p.m. ET BURLINGTON, Mass, Nov. 12, 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 reported its third quarter 2024 finan
11/12/24 4:05:42 PM ET
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Fractyl Health to Report Third Quarter 2024 Financial Results and Provide Business Updates on November 12, 2024
BURLINGTON, Mass., Oct. 29, 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 report financial results for the third quarter 2024 and provide business updates on Tuesday, November 12, 2024, at 4:30 p.m. ET. A live webcast of the conference call can be accessed in the "Events" section of Fractyl's website at https://ir.fractyl.com/. The webcast will be archived and available for replay following the live event. About Fractyl Health Fractyl Health is a metabolic therapeutics company focused on pioneeri
10/29/24 7:00:00 AM ET
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Fractyl 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 lower blood sugar for at least one-year post-treatment in a real-world setting Granted U.S. FDA Breakthrough Device designation for Revita in weight maintenance after discontinuation of GLP-1 based drugs REMAIN-1 pivotal study for Revita in weight maintenance now initiated with anticipated data readouts beginning in Q4 2024 REVITALIZE-1 on-track to report topline data in mid-2025 in expanded Type 2 Diabetes patient population Presented head-to-head preclinical data comparing Rejuva® versus semaglutide in #1 abstract at ADA 2024 Conference call today at 4:30
8/14/24 4:05:00 PM ET
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Fractyl Health Presents Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva at Digestive Disease Week 2024

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$GUTS Market Insights

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Fractyl Health Accelerates Key Clinical Trials for Obesity and Diabetes Treatments

Reported Earlier, Fractyl Health Unveils Preclinical Data on Obesity and Diabetes Gene Therapy

Fractyl Health Announced Single Administration Of Rejuva Reduced Fat Mass And Improved Glycemia In The Well-validated Diet-induced Obesity Mouse Model

$GUTS Large Ownership Changes

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SEC Form SC 13G filed by Fractyl Health Inc.

SEC Form SC 13G filed by Fractyl Health Inc.

SEC Form SC 13G filed by Fractyl Health Inc.

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Chief Executive Officer Rajagopalan Harith converted options into 216,924 shares and sold $238,358 worth of shares (96,517 units at $2.47), increasing direct ownership by 32% to 491,329 units (SEC Form 4)

President, Chief Product Off. Caplan Jay David converted options into 187,257 shares and sold $158,541 worth of shares (64,197 units at $2.47), increasing direct ownership by 404% to 153,544 units (SEC Form 4)

President, Chief Product Off. Caplan Jay David exercised 95,484 shares at a strike of $1.70 and sold $188,474 worth of shares (65,000 units at $2.90) (SEC Form 4)

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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 Appoints Samuel Conaway to Its Board of Directors, Bolstering New Product Commercial Expertise During Revita® Pivotal Clinical Trials

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Fractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates

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 Presented New Analysis from Pooled Data of Revita® Clinical Studies Demonstrating Durable Weight Loss Maintenance for One Year at ObesityWeek® 2024

$GUTS SEC Filings

Fractyl Health Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

SEC Form 10-Q filed by Fractyl Health Inc.

Fractyl Health Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

$GUTS Financials

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Fractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates

Fractyl Health to Report Third Quarter 2024 Financial Results and Provide Business Updates on November 12, 2024

Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates

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Evercore ISI initiated coverage on Fractyl Health

Morgan Stanley initiated coverage on Fractyl Health with a new price target

BofA Securities initiated coverage on Fractyl Health with a new price target

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