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Fractyl Health, Inc. - GUTS STOCK NEWS

Welcome to our dedicated page for Fractyl Health news (Ticker: GUTS), a resource for investors and traders seeking the latest updates and insights on Fractyl Health stock.

Fractyl Health, Inc. (Nasdaq: GUTS) is a pioneering metabolic therapeutics company based in Burlington, MA, dedicated to transforming the treatment of metabolic diseases such as type 2 diabetes (T2D) and obesity. The company aims to shift the paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of these conditions at the organ level.

Fractyl Health's leading product candidate, Revita®, focuses on remodeling the duodenal lining through hydrothermal ablation, known as duodenal mucosal resurfacing (DMR). This innovative approach aims to correct abnormal intestinal nutrient sensing and signaling mechanisms, which are potential root causes of metabolic diseases like T2D and obesity. Revita has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the United States, Revita is for investigational use only. The company is currently enrolling patients in pivotal studies such as Revitalize-1 and Remain-1 to further investigate the efficacy of Revita.

Additionally, Fractyl Health's Rejuva® platform is in the preclinical development stage, focusing on next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies. The platform aims to offer novel, disease-modifying therapies that target the pancreas, leveraging advanced delivery systems and proprietary screening methods.

Recently, Fractyl Health presented new preclinical data from its Rejuva platform at the Digestive Disease Week (DDW) 2024, showcasing the potential of GLP-1 based pancreatic gene therapy to reduce liver fat in diet-induced obesity models. The company also shared impressive 6-month follow-up data from its German real-world registry study of Revita for T2D, highlighting significant improvements in blood sugar levels, body weight, and medication burden among participants.

Fractyl Health continues to advance its mission with promising research and active participation in major medical conferences. The company’s strategic goals include progressing towards regulatory approvals and expanding clinical studies to validate their innovative therapies.

For more information, visit www.fractyl.com or follow Fractyl Health on Twitter.

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Fractyl Health, Inc. presented promising 6-month follow-up data from its German real-world registry study of Revita for advanced Type 2 Diabetes (T2D). Participants showed sustained improvements in blood glucose, weight loss, and reduced T2D medication use after a single treatment. No serious adverse events related to the device or procedure have been reported. These results indicate the potential of Revita for durable weight loss maintenance.

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Fractyl Health, Inc. (Nasdaq: GUTS) will present at BofA Securities 2024 Health Care Conference. Dr. Harith Rajagopalan, CEO, will participate in a fireside chat on May 15, 2024. The Company focuses on innovative treatments for obesity and type 2 diabetes.

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Fractyl Health, Inc. (Nasdaq: GUTS) will report Q1 2024 financial results and business updates on May 13, 2024. The company focuses on metabolic therapeutics for obesity and T2D, hosting a conference call at 4:30 p.m. ET.

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Fractyl Health, Inc. (Nasdaq: GUTS) will present new data at the German Diabetes Association (DDG) Annual Meeting on its real-world registry study of Revita for T2D and at the Digestive Disease Week (DDW) on the potential of Rejuva in reducing liver fat. The presentations include clinical updates and preclinical data demonstrating the effectiveness of their metabolic therapeutics in treating obesity and T2D.

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Fractyl Health, Inc. appoints Adrian Kimber as Chief Commercial Officer, bringing extensive experience in biotechnology and medical devices. The company aims to launch its Revita® system for treating obesity and Type 2 diabetes, with Mr. Kimber's expertise crucial for success.
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Fractyl Health (Nasdaq: GUTS) received IDE approval for the Revita Remain-1 pivotal study for weight maintenance in obese patients discontinuing GLP-1 based drugs. They completed enrollment in the Revitalize-1 study for T2D patients and announced RJVA-001 as the first Rejuva GLP-1 gene therapy candidate. The company raised $110 million in an IPO, ensuring funding through 2025.
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Fractyl Health, Inc. receives FDA approval for pivotal study on Revita to maintain weight loss post GLP-1RA discontinuation, addressing obesity treatment gap. Remain-1 trial to begin in 2024, targeting durable weight maintenance. Revita aims to offer lasting weight loss benefits after stopping GLP-1 based drugs.
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Fractyl Health, Inc. announces promising preclinical results for RJVA-001, its first GLP-1 gene therapy candidate, showcasing significant glucose lowering and weight loss in db/db mice. The human GLP-1 transgene sequence in RJVA-001 demonstrated up to 50% blood sugar reduction and 11% weight loss compared to chronic semaglutide. These findings pave the way for a potentially transformative approach to treating obesity and type 2 diabetes.
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Fractyl Health, Inc. (Nasdaq: GUTS) appoints Samuel Conaway to its Board of Directors, bringing extensive experience in medical technology commercialization. His leadership will aid in pivotal clinical studies for Type 2 Diabetes and weight loss maintenance, emphasizing the company's commitment to developing innovative treatment options.
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Fractyl Health (Nasdaq: GUTS) announced the pricing of its initial public offering of 7,333,333 shares of common stock at a public offering price of $15.00 per share, for total gross proceeds of approximately $110.0 million. The offering is expected to close on February 6, 2024, and Fractyl Health has granted the underwriters a 30-day option to purchase up to an additional 1,099,999 shares of its common stock at the initial public offering price. The company's common stock is expected to begin trading on the Nasdaq Global Market on February 2, 2024, under the ticker symbol 'GUTS'. BofA Securities, Morgan Stanley, and Evercore ISI are acting as joint book-running managers. A registration statement relating to the securities being sold in the offering has been declared effective by the U.S. Securities and Exchange Commission on February 1, 2024.
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FAQ

What is the current stock price of Fractyl Health (GUTS)?

The current stock price of Fractyl Health (GUTS) is $1.79 as of December 20, 2024.

What is the market cap of Fractyl Health (GUTS)?

The market cap of Fractyl Health (GUTS) is approximately 86.6M.

What is Fractyl Health, Inc.?

Fractyl Health is a metabolic therapeutics company focused on developing disease-modifying therapies for metabolic diseases like type 2 diabetes and obesity.

What is Revita®?

Revita® is Fractyl Health's lead product candidate designed to remodel the duodenal lining through hydrothermal ablation, aiming to correct abnormal nutrient sensing and signaling mechanisms in the gut.

What is the Rejuva® platform?

Rejuva® focuses on developing AAV-based, locally delivered gene therapies targeting the pancreas to offer disease-modifying treatments for obesity and T2D.

Is Revita® approved for use?

Revita® has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the U.S., it is currently for investigational use only.

What recent achievements has Fractyl Health made?

Fractyl Health has presented promising preclinical data from its Rejuva platform and shared significant 6-month follow-up results from its Revita real-world registry study.

Where is Fractyl Health located?

Fractyl Health is based in Burlington, Massachusetts.

What are the ongoing clinical studies for Revita®?

The ongoing pivotal studies for Revita® include Revitalize-1 for patients with inadequately controlled T2D and Remain-1 for patients with obesity after discontinuation of GLP-1 based drugs.

How can I learn more about Fractyl Health?

For more information, visit their website at www.fractyl.com or follow them on Twitter at @FractylHealth.

What is the mission of Fractyl Health?

Fractyl Health aims to transform the treatment of metabolic diseases from chronic symptomatic management to durable disease-modifying therapies.

Who should I contact for investor relations?

For investor inquiries, contact Stephen Jasper at Gilmartin Group, email: stephen@gilmartinir.com.

Fractyl Health, Inc.

Nasdaq:GUTS

GUTS Rankings

GUTS Stock Data

86.58M
45.77M
4.84%
88.82%
4.11%
Biotechnology
Surgical & Medical Instruments & Apparatus
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United States of America
BURLINGTON