Fractyl Health to present preclinical data on Rejuva gene therapy for obesity and type 2 diabetes at ASGCT 2025.
Quiver AI Summary
Fractyl Health, Inc. announced that it will present preclinical data on its Rejuva gene therapy platform, which targets obesity and type 2 diabetes, at the American Society of Gene and Cell Therapy Annual Meeting from May 13-17, 2025, in New Orleans. The oral presentation, titled "Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model," is scheduled for May 17 at 9:15 a.m. CT. Fractyl Health focuses on innovative metabolic therapies aimed at treating the underlying causes of these diseases rather than just managing symptoms. The Rejuva platform is still in preclinical development, with plans to submit a Clinical Trial Application for its RJVA-001 therapy in early 2025, anticipating preliminary results by 2026.
Potential Positives
- Fractyl Health will present compelling preclinical data at a significant scientific conference, enhancing its visibility in the field of metabolic therapeutics.
- The presentation of its innovative Rejuva platform highlights the company's commitment to pioneering disease-modifying therapies for obesity and type 2 diabetes.
- The planned submission of a Clinical Trial Application for RJVA-001 demonstrates forward momentum and potential for future development in treating type 2 diabetes.
Potential Negatives
- The Rejuva platform is still in preclinical development and has not yet been evaluated by regulatory agencies, indicating a lack of regulatory validation and potential future hurdles.
- The expectation to submit the first Clinical Trial Application (CTA) module for RJVA-001 in H1 2025, with preliminary data not anticipated until 2026, suggests a lengthy timeline before any potential therapeutic benefit can be realized.
FAQ
What is Fractyl Health focused on?
Fractyl Health is dedicated to developing metabolic therapeutics to address obesity and type 2 diabetes (T2D) at their root causes.
When will Fractyl present at the ASGCT Annual Meeting?
Fractyl will present preclinical data on May 17, 2025, at the ASGCT Annual Meeting in New Orleans, Louisiana.
What is the topic of Fractyl's oral presentation?
The presentation is titled "Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy."
Where can I find the presentation after it occurs?
The presentation will be available on the Presentations & Publications section of the Fractyl website after May 17, 2025.
What is the Rejuva platform developed by Fractyl?
The Rejuva platform focuses on next-generation gene therapies aimed at treating obesity and T2D, currently in preclinical development.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$GUTS Insider Trading Activity
$GUTS insiders have traded $GUTS stock on the open market 11 times in the past 6 months. Of those trades, 5 have been purchases and 6 have been sales.
Here’s a breakdown of recent trading of $GUTS stock by insiders over the last 6 months:
- HARITH RAJAGOPALAN (Chief Executive Officer) has made 0 purchases and 3 sales selling 208,437 shares for an estimated $444,361.
- JAY DAVID CAPLAN (President, Chief Product Off.) has made 0 purchases and 3 sales selling 108,015 shares for an estimated $240,806.
- KELLY ANN BARNES purchased 31,000 shares for an estimated $40,210
- AJAY ROYAN purchased 17,901 shares for an estimated $22,979
- WILLIAM BRADLEY purchased 16,129 shares for an estimated $20,358
- AMY W SCHULMAN purchased 8,550 shares for an estimated $9,964
- SAMUEL CONAWAY purchased 8,550 shares for an estimated $9,964
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$GUTS Hedge Fund Activity
We have seen 34 institutional investors add shares of $GUTS stock to their portfolio, and 22 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ENSIGN PEAK ADVISORS, INC removed 1,408,852 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,902,235
- VANGUARD GROUP INC added 792,770 shares (+151.9%) to their portfolio in Q4 2024, for an estimated $1,633,106
- BLACKROCK, INC. added 251,119 shares (+11.2%) to their portfolio in Q4 2024, for an estimated $517,305
- NORGES BANK removed 213,541 shares (-68.1%) from their portfolio in Q4 2024, for an estimated $439,894
- MORGAN STANLEY added 103,549 shares (+61.9%) to their portfolio in Q4 2024, for an estimated $213,310
- BLACKSTONE INC. added 102,750 shares (+inf%) to their portfolio in Q4 2024, for an estimated $211,665
- CITADEL ADVISORS LLC removed 90,821 shares (-11.0%) from their portfolio in Q4 2024, for an estimated $187,091
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
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
Presentations & Publications
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
www.fractyl.com
.
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
[email protected], 978.760.5622
Investor Contact
Brian Luque, Head of Investor Relations and Corporate Development
[email protected], 951.206.1200
