Fractyl Health

Fractyl Health

Develops Rejuva gene therapy for T2D

Overview

Fractyl Health focuses on developing therapies for Type 2 Diabetes and obesity, aiming to address root causes of these metabolic diseases. Its lead program, Rejuva, is a gene therapy platform intended to improve pancreatic islet cell function to achieve long-term remission or control of blood sugar. Rejuva is in preclinical development and overseen by the FDA, with a CE mark enabling commercial use in the European Economic Area. Revenue comes from developing, securing regulatory approvals, and bringing therapies to market through adoption by healthcare providers and patients. The company differentiates itself by targeting pancreatic islet cell function rather than just symptoms, and by pursuing a gene therapy approach intended for durable effects. The goal is to provide transformative, durable treatments that prevent or reverse T2D and obesity by addressing their root causes.

About Fractyl Health

Simplify's Rating
Why Fractyl Health is rated
C-
Rated C on Competitive Edge
Rated C on Growth Potential
Rated D+ on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

IPO

Headquarters

Lexington, Kentucky

Founded

2010

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Simplify's Take

What believers are saying

  • August 10, 2026 results kept $47.1 million cash and runway into early 2027.
  • REMAIN-1 pivotal topline data stays scheduled for early Q4 2026, with De Novo later.
  • RJVA-001 received Netherlands authorization, positioning Rejuva for first dosing in H2 2026.

What critics are saying

  • Robbins LLP filed a class action over January 29, 2026 Revita disclosures.
  • Nasdaq warned on March 13, 2026; Fractyl must cure sub-$1.00 shares by September 9.
  • A failed REMAIN-1 readout destroys Revita’s FDA path and likely forces dilutive financing.

What makes Fractyl Health unique

  • Revita targets post-GLP-1 weight maintenance with a one-time endoscopic duodenal reset.
  • Fractyl pairs Revita with Rejuva, a pancreatic gene-therapy platform entering first-in-human testing.
  • FDA Breakthrough Device designation and CE Mark give Revita unusual regulatory credibility.

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Funding

Total Funding

$500.2M

Above

Industry Average

Funded Over

10 Rounds

Post IPO Equity funding comparison data is currently unavailable. We're working to provide this information soon!
Post IPO Equity Funding Comparison
Coming Soon

Benefits

Remote Work Options

Stock Price

Growth & Insights and Company News

Headcount

6 month growth

-3%

1 year growth

-1%

2 year growth

1%
Trade Show News
Aug 21st, 2026
Stockholder alert: Robbins LLP informs investors of the Fractyl Health, Inc. Class Action.

Stockholder alert: Robbins LLP informs investors of the Fractyl Health, Inc. Class Action. SAN DIEGO-(BUSINESS WIRE)-Shareholder rights law firm Robbins LLP informs investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired Fractyl Health, Inc. (NASDAQ: GUTS) securities between January 13, 2025 and January 29, 2026 (the "Class Period"). Fractyl is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes ("T2D") and obesity. Robbins LLP is Investigating Allegations that Fractyl Health misled investors regarding the viability and efficacy of its Revita DMR System. Share The complaint alleges that Fractyl Health misled investors regarding the viability and efficacy of its Revita DMR System. Investors who suffered significant losses during the Class Period may be eligible to participate in the lawsuit and should contact Robbins LLP for information. Why Was Fractyl Health Sued? According to the complaint, Fractyl is developing, inter alia, the Revita DMR System ("Revita"), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet. The complaint alleges that during the Class Period, defendants failed to disclose that: * Revita was less effective than defendants had led investors to believe, and/or operational issues at one or more of the REMAIN-1 Midpoint Cohort's clinical sites compromised the integrity of its efficacy results; * accordingly, Revita's clinical, regulatory, and commercial prospects were overstated, as was the REMAIN-1 Midpoint Cohort's ability to assess Revita's efficacy; and * as a result, defendants' public statements were materially false and misleading at all relevant times. Why Did Fractyl Health's Stock Drop? Plaintiff alleges that on January 29, 2026, during pre-market hours, Fractyl issued a press release announcing six-month data from the REMAIN-1 Midpoint Cohort. The press release disclosed, in relevant part, that "[a]cross the prespecified efficacy population..., Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months", representing a significantly more modest efficacy result than previously disclosed results and falling short of investor expectations, while stating that "[t]he Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis[.]" The same day, also during pre-market hours, Fractyl hosted a conference call with investors and analysts to discuss the six-month data from the REMAIN-1 Midpoint Cohort. During the call, Fractyl's CEO defendant Harith Rajagopalan indicated that issues at one of the REMAIN-1 Midpoint Cohort study sites, which "had higher-than-expected regain across both arms," were at least partly to blame for the cohort's disappointing six-month efficacy results. Following these disclosures, Fractyl's stock price fell $1.245 per share, or 68.03%, to close at $0.585 per share on January 29, 2026. On the same day, during post-market hours Morgan Stanley downgraded the stock to an "Equal-weight" from "Overweight" rating and cut its target price on the Company's stock to $2.00 from $8.00. On this news, Fractyl Health's stock fell another 21.7%, to close at $0.46 per share on January 30, 2026. Who Can Participate in the Fractyl Health Class Action? The lawsuit seeks to represent investors who purchased or otherwise acquired Fractyl Health common stock between January 13, 2025 and January 29, 2026. Investors who suffered losses during that period may have legal rights under the federal securities laws. What Is a Lead Plaintiff? The lead plaintiff is a court-appointed investor who represents the interests of all class members throughout the litigation. Serving as lead plaintiff is not required to share in any potential recovery. Investors who do not seek appointment may remain absent class members if the case proceeds and later resolves successfully. Shareholders who wish to lead the case should contact Robbins LLP. Does it cost anything to participate? No. Robbins LLP represents investors on a contingency fee basis. Fees and litigation expenses are paid by defendants only if there is a recovery. Contact Robbins LLP Investors seeking additional information about the Fractyl Health Inc. securities class action may contact Robbins LLP by submitting an inquiry, emailing attorney Aaron Dumas, Jr., or calling (800) 350-6003. About Robbins LLP Robbins LLP is a shareholder rights law firm focused on representing investors in securities fraud and shareholder litigation. The firm has helped recover more than $1 billion for investors, obtained significant corporate governance reforms, and has represented shareholders in cases involving alleged violations of the federal securities laws. "Companies have an obligation to provide investors with complete and accurate information so that markets can function fairly and efficiently," said Brian J. Robbins, Founding Partner of Robbins LLP. To be notified if a class action against Fractyl Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today. Attorney Advertising. Past results do not guarantee a similar outcome. Contacts. Aaron Dumas, Jr. Robbins LLP 5060 Shoreham Pl., Ste. 300 San Diego, CA 92122 [email protected] (800) 350-6003 www.robbinsllp.com More News From Robbins LLP SAN DIEGO-( BUSINESS WIRE )-Shareholder rights law firm Robbins LLP informs investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired GoDaddy Inc. (NYSE: GDDY) common stock between September 3, 2025 and February 24, 2026 (the "Class Period"). GoDaddy is an internet domain registry, domain registrar, and web hosting company headquartered in Tempe, Arizona.The complaint alleges that GoDaddy failed to disclose to investors that it had initiate... SAN DIEGO-( BUSINESS WIRE )-Shareholder rights law firm Robbins LLP informs investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired AEVEX Corp. (NYSE: AVEX) Class A common stock (a) between April 17, 2026 and June 4, 2026, and (b) pursuant to the Company's initial public offering ("IPO") on April 17, 2026 (the "Class Period"). AEVEX is a military technology contractor.The complaint alleges that AEVEX concealed a pre-arranged plan between... SAN DIEGO-( BUSINESS WIRE )-Shareholder rights law firm Robbins LLP is investigating Wealthfront Corporation (NASDAQ: WLTH) to determine whether certain Wealthfront officers and directors violated securities laws and breached fiduciary duties to shareholders.Why Are Business Wire, Inc. Investigating Wealthfront?Wealthfront completed its initial public offering in December 2025, offering 34,615,384 shares of common stock at $14.00 per share, including shares sold by the Company and selling stockholders. The Compa...

Yahoo Finance
Aug 14th, 2026
Fractyl Health eyes Q4 Revita data, launches Rejuva gene therapy trial

Fractyl Health is preparing to release pivotal data for its Revita procedure in early Q4 and has begun enrolling patients in a gene therapy trial for metabolic disease. Revita is a one-time endoscopic procedure that ablates part of the duodenum to address metabolic dysfunction. The company's 300-patient trial is testing whether the procedure can prevent weight regain after tirzepatide-assisted weight loss, with 12-month results expected in Q1. In pilot studies, patients who lost 40 to 50 pounds on tirzepatide maintained over 80% of that weight loss at one year following Revita. Control groups regained approximately 60% of lost weight. Fractyl has also received FDA clearance for its Rejuva gene therapy trial, which aims to induce pancreatic beta cells to produce GLP-1 locally. Patient enrollment is expected later this year.

Associated Press
Aug 10th, 2026
Fractyl Health reports Q2 2026 results, pivotal Revita weight maintenance data due early Q4 2026

Fractyl Health reported second quarter 2026 financial results, announcing one-year data from its REMAIN-1 weight maintenance trials for its Revita procedure. The REMAIN-1 Midpoint Cohort showed patients receiving complete duodenal ablations maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham treatment. The open-label REVEAL-1 Cohort demonstrated patients maintained approximately 78% of their GLP-1-induced weight loss after a single Revita procedure. The company reiterated its timeline for topline REMAIN-1 Pivotal Cohort data in early Q4 2026 and potential FDA De Novo submission in late Q4 2026. Fractyl reported second quarter net loss of $25.5 million and held approximately $47.1 million in cash as of 30 June 2026. Management guided cash runway into early 2027, beyond anticipated pivotal data readout.

Citybiz
Jun 1st, 2026
Fractyl Health appoints Mike Zumdahl to lead market access strategy for Revita.

Fractyl Health appoints Mike Zumdahl to lead market access strategy for Revita. June 1, 2026 Mike Zumdahl Fractyl Health has hired medtech reimbursement and market access executive Mike Zumdahl as senior vice president of market access and commercial strategy, a move that shifts the company's focus beyond clinical development and toward the commercialization infrastructure needed to support its lead obesity therapy candidate, Revita. The appointment comes as the Burlington, Massachusetts-based metabolic therapeutics company prepares for topline data from the pivotal cohort of its REMAIN-1 trial in early fourth quarter 2026. Positive results could support a De Novo marketing application submission to the U.S. Food and Drug Administration later in the quarter, positioning Revita for a potential entry into the emerging post-GLP-1 weight maintenance market. Zumdahl will be responsible for building the reimbursement, health economics and market access framework for Revita, a one-time endoscopic procedure designed to remodel the duodenal lining and restore metabolic signaling disrupted by obesity and type 2 diabetes. The company has identified patient retention after GLP-1 therapy as a significant commercial and clinical challenge, citing high discontinuation rates among users of weight-loss medications. Unlike pharmaceutical obesity treatments that require ongoing use, Revita is being developed as a procedural intervention intended to help patients maintain weight loss after stopping GLP-1 drugs. That positioning creates a different commercialization challenge, requiring physician adoption, payer reimbursement strategies and evidence demonstrating economic value alongside clinical outcomes. Fractyl CEO and co-founder Dr. Harith Rajagopalan said the company is entering a critical stage where reimbursement planning and health economics become increasingly important to long-term adoption. Zumdahl arrives with experience building market access functions for emerging medical technologies. Most recently, he served as president of Commercial Access Partners, advising medtech companies on reimbursement and go-to-market strategy. Before that, he led global health economics, market access and government affairs at Inari Medical, helping develop the commercial infrastructure for the company's catheter-based vascular therapies before its approximately $4.9 billion acquisition by Stryker in 2025. His background also includes nearly a decade at Novo Nordisk, where he worked in national accounts, government payer relations and health economics roles during the expansion of the GLP-1 category. That experience gives Fractyl leadership familiar with both sides of the obesity treatment landscape as the company attempts to establish a procedural alternative for patients discontinuing drug therapy. "The post-GLP-1 weight maintenance problem represents the largest unmet need I have seen in metabolic disease in the last twenty years," Zumdahl said. He noted that his focus will be developing the reimbursement architecture and commercial strategy needed to support patient access if Revita reaches the market. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. While the therapy remains investigational in the United States, it has obtained CE Mark certification in the European Union and the United Kingdom. The hire reflects a broader trend among late-stage medtech companies that begin building payer, reimbursement and health economics capabilities well before regulatory approval. For Fractyl, success will depend not only on upcoming clinical data but also on demonstrating that a one-time procedural treatment can fit within existing obesity care pathways and reimbursement systems. Alongside Revita, Fractyl is advancing its Rejuva gene therapy platform for obesity and type 2 diabetes. However, with pivotal trial results expected later this year, Revita remains the company's most immediate commercial opportunity and a central focus of its operational planning.

Associated Press
Jun 1st, 2026
Fractyl Health hires ex-Inari Medical VP Mike Zumdahl ahead of Q4 pivotal data readout

Fractyl Health, a clinical-stage metabolic therapeutics company, has appointed Mike Zumdahl as senior vice president of market access and commercial strategy. The appointment comes as the company prepares for its REMAIN-1 pivotal cohort topline readout in early Q4 2026 and a potential De Novo marketing application submission for its Revita therapy in late Q4 2026. Zumdahl previously served as vice president of global health economics, market access and government affairs at Inari Medical before its $4.9 billion acquisition by Stryker in February 2025. He also spent nearly a decade at Novo Nordisk in roles including national accounts and government payers, contributing to health economics strategy for GLP-1 therapies. Fractyl is developing Revita for post-GLP-1 weight maintenance in people with obesity.

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