| Forge Biologics Announces AAV Development and cGMP Manufacturing Relationship with Fractyl Health to Advance Their Gene Therapy Platform for Patients with Metabolic Diseases |
COLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health's Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D). "We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help. |
businesswire.com |
2025-05-14 13:25:00 |
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| Fractyl Health, Inc. (GUTS) Q1 2025 Earnings Call Transcript |
Fractyl Health, Inc. (NASDAQ:GUTS ) Q1 2025 Earnings Conference Call May 13, 2025 4:30 PM ET Company Participants Brian Luque - Head of Investor Relations and Corporate Development Harith Rajagopalan - Co Founder and Chief Executive Officer Lisa Davidson - Chief Financial Officer and Treasurer Conference Call Participants Avi Novick - Morgan Stanley Michael DiFiore - Evercore ISI Whitney Ijem - Canaccord Genuity Operator Good afternoon. And welcome to Fractyl Health's First Quarter 2025 Financial Results and Business Updates Call. |
seekingalpha.com |
2025-05-14 00:43:14 |
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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 module submission for RJVA-001 expected in June 2025 Conference call today at 4:30 p.m. ET BURLINGTON, Mass. |
globenewswire.com |
2025-05-13 20:05:00 |
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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. |
globenewswire.com |
2025-05-06 11:00:00 |
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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 place May 13-17, 2025, in New Orleans, Louisiana. |
globenewswire.com |
2025-04-28 20:30:00 |
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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 cohort of its ongoing REMAIN-1 pivotal study. |
globenewswire.com |
2025-04-01 11:00:00 |
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| Fractyl Health, Inc. (GUTS) Q4 2024 Earnings Call Transcript |
Fractyl Health, Inc. (NASDAQ:GUTS ) Q4 2024 Earnings Conference Call March 3, 2025 4:30 PM ET Company Participants Brian Luque – Head of Investor Relations and Corporate Development Harith Rajagopalan – Chief Executive Officer Lisa Davidson – Chief Financial Officer Conference Call Participants Mike Ulz – Morgan Stanley Michael DiFiore – Evercore ISI William Wood – B. Riley Securities Operator Good afternoon, and welcome to Fractyl Health's Fourth Quarter and Full Year 2024 Financial Results and Business Updates Call. |
seekingalpha.com |
2025-03-03 22:01:49 |
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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 |
globenewswire.com |
2025-03-03 18:05:00 |
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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. |
globenewswire.com |
2025-02-24 09:00:00 |
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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.com |
2025-02-12 12:36:23 |
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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 |
globenewswire.com |
2025-01-31 10:01:00 |
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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 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), will present new data from its preclinical Rejuva Smart GLP-1 pancreatic gene therapy program in a poster titled “Feasibility and Safety of Novel Endoscopic Ultrasound-Guided Delivery of Human GLP-1 Pancreatic Gene Therapy in Pigs” at the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC). |
globenewswire.com |
2024-12-12 09:00:00 |
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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. |
globenewswire.com |
2024-12-09 09:00:00 |
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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. |
globenewswire.com |
2024-11-26 09:00:00 |
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| Fractyl Health, Inc. (GUTS) Q3 2024 Earnings Call Transcript |
Fractyl Health, Inc. (NASDAQ:GUTS ) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-Founder and CEO Lisa Davidson - CFO Conference Call Participants Michael Ulz - Morgan Stanley Michael DiFiore - Evercore ISI William Wood - B. Riley Securities Operator Good afternoon, and welcome to Fractyl Health's Third Quarter Financial Results and Business Updates Call. |
seekingalpha.com |
2024-11-15 01:01:04 |
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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 financial results and provided business updates. |
globenewswire.com |
2024-11-12 18:05:00 |
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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 |
globenewswire.com |
2024-11-04 18:05:00 |
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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. |
globenewswire.com |
2024-10-29 09:00:00 |
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| Fractyl Health to Present Compelling Weight Maintenance Data from both Revita® and Rejuva® Platforms at ObesityWeek® 2024 |
BURLINGTON, Mass., Oct. 28, 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 it will present compelling weight maintenance data from both its Revita and Rejuva platforms at The Obesity Society's Annual Meeting at ObesityWeek 2024, held from November 2-6, 2024, in San Antonio, Texas. |
globenewswire.com |
2024-10-28 09:00:00 |
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| Fractyl Health to Present at Chardan's 8th Annual Genetic Medicines Conference |
BURLINGTON, Mass., Sept. 24, 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. |
globenewswire.com |
2024-09-24 11:00:00 |
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| Fractyl Health to Participate in Upcoming September Investor Conferences |
BURLINGTON, Mass., Sept. 03, 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. |
globenewswire.com |
2024-09-03 11:00:00 |
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| Fractyl Health, Inc. (GUTS) Q2 2024 Earnings Call Transcript |
Fractyl Health, Inc. (NASDAQ:GUTS ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Conference Call Participants Michael Ulz - Morgan Stanley Umer Raffat - Evercore Operator Good afternoon, and welcome to Fractyl Health's Second Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. |
seekingalpha.com |
2024-08-15 01:27:07 |
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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 p.m. ET BURLINGTON, Mass. |
globenewswire.com |
2024-08-14 20:05:00 |
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| Fractyl Health to Report Second Quarter 2024 Financial Results and Provide Business Updates on August 14, 2024 |
BURLINGTON, Mass., Aug. 07, 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 second quarter 2024 and provide business updates on Wednesday, August 14, 2024, at 4:30 p.m. |
globenewswire.com |
2024-08-07 11:00:00 |
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| Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs |
Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs |
globenewswire.com |
2024-07-30 11:00:00 |
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| Fractyl Health to Present at Piper Sandler 2nd Annual Virtual Obesity Day |
BURLINGTON, Mass., June 25, 2024 (GLOBE NEWSWIRE) -- 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 announced that Dr. Harith Rajagopalan, CEO of Fractyl Health, and Dr. Timothy Kieffer, CSO of Fractyl Health, will participate in a virtual fireside chat at the upcoming Piper Sandler 2nd Annual Virtual Obesity Day on Wednesday, June 26, 2024 at 9:30 a.m. |
globenewswire.com |
2024-06-25 11:00:00 |
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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 and mid-point data analysis for REMAIN-1 anticipated in Q2 2025 Company expands Revita type 2 diabetes clinical study REVITALIZE-1, expanding eligibility; increases potential U.S. treatment population for Revita by over 6x (from ~4 to ~25 million patients) Company presented preclinical data showing greater, more durable weight loss for its GLP-1 pancreatic gene therapy Rejuva® vs. semaglutide in one of eight President Select Abstracts at the American Diabetes Association's 84 th Scientific Sessions BURLINGTON, Mass. |
globenewswire.com |
2024-06-24 10:00:00 |
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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 |
Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas BURLINGTON, Mass., June 23, 2024 (GLOBE NEWSWIRE) -- 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. |
globenewswire.com |
2024-06-23 17:30:00 |
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| Fractyl Health Presents Compelling Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva® at Digestive Disease Week 2024 |
Results showed single-administration GLP-1 pancreatic gene therapy candidate reduced liver weight by 42% (p |
globenewswire.com |
2024-05-20 10:00:00 |
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| Fractyl Health, Inc. (GUTS) Q1 2024 Earnings Call Transcript |
Fractyl Health, Inc. (NASDAQ:GUTS ) Q1 2024 Earnings Conference Call May 13, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Timothy Kieffer - Chief Scientific Officer Adrian Kimber - Chief Commercial Officer Conference Call Participants Michael DiFiore - Evercore ISI Michael Ulz - Morgan Stanley Operator Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. |
seekingalpha.com |
2024-05-14 02:37:09 |
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| Fractyl 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 expected in the second half of 2024 Topline data from Revitalize-1 pivotal study in patients with inadequately controlled T2D anticipated in the fourth quarter 2024 Update from real-world Germany registry study of Revita in patients with T2D at DDG Annual Meeting Appointed Adrian Kimber as Chief Commercial Officer to lead Revita launch readiness activities Conference call today at 4:30 p.m. ET BURLINGTON, Mass. |
globenewswire.com |
2024-05-13 20:00:00 |
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