GUTS FRACTYL HEALTH INC

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

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.

Oral Presentation Details:

Title: Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model

Session: AAV Preclinical and Proof-of-Concept Studies

Date and Time: Saturday, May 17, 2025, 9:15 a.m. – 9:30 a.m. CT

Location: NOLA Theater A

The presentation will be available via the section of the Fractyl website once it concludes on May 17, 2025.



About Fractyl Health

Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit .



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 is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if the CTA is authorized, expects to report preliminary data in 2026.

Contacts 

Media Contact 

Jessica Cotrone, Head of Corporate Communications 

, 978.760.5622

Investor Contact

Brian Luque, Head of Investor Relations and Corporate Development

, 951.206.1200



EN
28/04/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on FRACTYL HEALTH INC

 PRESS RELEASE

Fractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of R...

Fractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of Revita® for Post-GLP-1 Weight Maintenance Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today ann...

 PRESS RELEASE

Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoi...

Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita’s potential to be the first d...

 PRESS RELEASE

Fractyl Health Appoints Lara Smith Weber as Chief Financial Officer to...

Fractyl Health Appoints Lara Smith Weber as Chief Financial Officer to Support Commercial-Stage Preparedness BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026. Ms. Smith Weber will oversee finance, accounting, and investor relations; and will serve as a key strategic partner to the C...

 PRESS RELEASE

Fractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Po...

Fractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Post-GLP-1 Weight Maintenance Therapeutic Category Randomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 Approximately $85.6 million in cash and cash equivalents on hand, supporting execution across planned 2026 milestones Received gross proceeds of $23.0 million from exercises of Tranche A warrants from August 2025 financing, with cash runway into early 2027 BURLINGTON, Mass., Jan. ...

 PRESS RELEASE

Fractyl Health Announces Call of Tranche A Warrants Tied to August 202...

Fractyl Health Announces Call of Tranche A Warrants Tied to August 2025 Public Offering Following Achievement of Clinical and Trading Milestones Holders will have until December 30, 2025 to exercise Tranche A Warrants at $1.05 per share, enabling up to $17.9 million in potential gross proceeds BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced that it will call...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch