Fractyl Health Unveils Groundbreaking Preclinical Data on Rejuva®: A Revolutionary Single-Administration Gene Therapy for Diabetes at ASGCT 2025

BURLINGTON, Mass., April 28, 2025 — Fractyl Health, Inc. (Nasdaq: GUTS) is breaking new ground in tackling obesity and type 2 diabetes. The company is set to present exciting preclinical findings from its Rejuva gene therapy platform at the upcoming American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting in New Orleans, from May 13-17, 2025.

Key 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

After the presentation, attendees can find the details on Fractyl’s website.

About Fractyl Health

Fractyl Health’s mission focuses on innovative treatments for metabolic diseases like obesity and type 2 diabetes. These conditions are becoming major health challenges. Despite various treatments emerging over the decades, obesity and T2D are on the rise, impacting life quality and length.

Fractyl aims to shift the approach from merely managing symptoms to offering solutions that target the root causes of these diseases. The company is based in Burlington, MA, and more information is available on their website at www.fractyl.com.

About the Rejuva Platform

Fractyl’s Rejuva platform explores next-generation gene therapies delivered directly to the pancreas for treating obesity and T2D. Currently in preclinical development, Rejuva is not yet approved for clinical use. This innovative method utilizes advanced delivery systems and unique screening processes to find effective gene therapy candidates.

Fractyl plans to submit its first Clinical Trial Application (CTA) module for RJVA-001, targeting type 2 diabetes, in the first half of 2025. If approved, the company hopes to share initial data in 2026.

Industry Insight

The obesity and diabetes epidemics have garnered attention globally. According to recent CDC data, over 40% of U.S. adults struggle with obesity. Advanced therapies like those from Fractyl may be key in addressing these complex health issues, aiming for long-term change rather than temporary fixes.

Summary

Fractyl Health is at the forefront of metabolic disease treatment, promising new hope in the fight against obesity and type 2 diabetes through innovative gene therapy methods. As the industry evolves, breakthroughs like the Rejuva platform could redefine how these conditions are approached. For further updates, check out reliable sources, such as the CDC for ongoing statistics and health information.

For media inquiries, contact Jessica Cotrone at jcotrone@fractyl.com, and for investor relations, reach out to Brian Luque at IR@fractyl.com.

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