Fractyl Health Enters a Catalyst-Rich 2026 Positioned to Define the Post-GLP-1 Weight Maintenance Therapeutic Category

Rhea-AI Summary

Fractyl Health (Nasdaq: GUTS) outlined a 2026 roadmap centered on pivotal clinical and regulatory milestones for its Revita and Rejuva programs and reported $85.6 million in cash and equivalents as of Jan 2, 2026.

Key near-term events include randomized 6-month REMAIN-1 Midpoint data in late January 2026, completion of REMAIN-1 pivotal cohort randomization in early 2026, REVEAL-1 1-year data in Q2 2026, and topline 6-month pivotal data with a potential Revita PMA filing in H2 2026. Rejuva aims for regulatory feedback in Q2 2026 and possible first-in-human dosing in H2 2026, subject to authorization.

Positive

• Cash balance of $85.6 million as of Jan 2, 2026
• Randomized 6-month REMAIN-1 Midpoint data expected late January 2026
• Potential Revita PMA filing targeted in H2 2026
• REVEAL-1 1-year cohort data expected Q2 2026
• Planned RJVA-001 first-in-human dosing in H2 2026 (subject to authorization)

Negative

• Cash runway projected only into early 2027
• Topline pivotal data and PMA filing timing remain conditional on trial results
• Rejuva FIH dosing subject to pending regulatory authorization

News Market Reaction

-8.44%

17 alerts

-8.44% News Effect

-9.7% Trough in 24 hr 4 min

-$27M Valuation Impact

$296M Market Cap

0.5x Rel. Volume

On the day this news was published, GUTS declined 8.44%, reflecting a notable negative market reaction. Argus tracked a trough of -9.7% from its starting point during tracking. Our momentum scanner triggered 17 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $27M from the company's valuation, bringing the market cap to $296M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & equivalents: $85.6 million Warrant proceeds: $23.0 million Preliminary cash: $81.5 million +1 more

4 metrics

Cash & equivalents $85.6 million Balance as of January 2, 2026 after warrant exercises

Warrant proceeds $23.0 million Gross proceeds from Tranche A warrant exercises from August 2025 financing

Preliminary cash $81.5 million Preliminary unaudited cash and cash equivalents as of December 31, 2025

Additional proceeds $4.1 million Further Tranche A warrant exercise proceeds received on January 2, 2026

Market Reality Check

Price: $0.4184 Vol: Volume 1,730,861 is below...

low vol

$0.4184 Last Close

Volume Volume 1,730,861 is below 20-day average of 3,600,206, suggesting limited pre-news positioning. low

Technical Shares at $2.25 are trading above the $1.50 200-day MA, reflecting an established uptrend ahead of 2026 milestones.

Peers on Argus

GUTS was up 2.27% pre-news. Peers were mixed: ADVM +2.83%, IMMX +3.23%, ACET +4....

GUTS was up 2.27% pre-news. Peers were mixed: ADVM +2.83%, IMMX +3.23%, ACET +4.63%, while ALGS -2.04% and XFOR -4.66%. With no peers in the momentum scanner and no same-day peer headlines, the setup appears stock-specific rather than a coordinated sector rotation.

Historical Context

5 past events · Latest: Dec 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	Warrant call / financing	Neutral	+0.0%	Call of Tranche A warrants tied to August 2025 offering to raise potential proceeds.
Dec 02	Clinical data update	Positive	+17.9%	Positive 6‑month REVEAL‑1 results showing sustained post‑GLP‑1 weight maintenance.
Dec 01	Conference participation	Neutral	-0.6%	Announcement of participation in the 8th Annual Evercore Healthcare Conference.
Nov 12	Earnings and pipeline	Positive	+2.7%	Q3 2025 results with positive REMAIN‑1 data, pivotal progress, and extended cash runway.
Nov 05	Earnings date notice	Neutral	+0.9%	Scheduling of Q3 2025 results call and business update webcast.

Pattern Detected

Recent history shows that positive clinical and financing updates have generally been followed by positive or stable price reactions, especially around Revita trial readouts and capital raises.

Recent Company History

Over the last few months, GUTS has combined clinical progress with balance sheet extension. In Q3 2025, the company highlighted positive REMAIN-1 data, a fully enrolled pivotal cohort, and runway into early 2027, with a modest +2.73% reaction. Positive 6‑month REVEAL‑1 data on Dec 2, 2025 saw a stronger +17.95% move. Subsequent warrant-related actions and conference participation produced flat-to-small moves. Today’s roadmap and cash-update announcement continues this narrative of clinical and regulatory milestones supported by recent financings.

Market Pulse Summary

The stock moved -8.4% in the session following this news. A negative reaction despite the outlined m...

Analysis

The stock moved -8.4% in the session following this news. A negative reaction despite the outlined milestones and cash of $85.6 million would fit a market focus on balance-sheet risk and past going‑concern language rather than long-dated catalysts. Historically, GUTS has reacted positively to clinical data, so a sharp decline on a planning update could reflect skepticism about execution or future funding needs rather than the 2026 roadmap itself, particularly with multiple pivotal and regulatory events still ahead.

Key Terms

glp-1, pma, clinical trial applications (cta), first-in-human, +2 more

6 terms

glp-1 medical

"With millions of patients expected to start and then stop taking a GLP-1 this year"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

pma regulatory

"Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected"

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

clinical trial applications (cta) regulatory

"completed Clinical Trial Applications (CTA) for a RJVA-001 FIH study in EU and Australia"

An application to a health authority requesting permission to begin testing a new drug or medical device in people, including the proposed study plan, safety data from lab and animal work, and how the product is made. Approval is a critical milestone because it lets a company move from lab research into human testing—similar to getting a building permit before construction—and approval, delay, or rejection can materially change development timelines, costs, and investor expectations.

first-in-human medical

"toward first-in-human (FIH) evaluation of its lead program, RJVA-001"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

gene therapy medical

"continue advancing its Rejuva gene therapy platform toward clinical validation in 2026"

Gene therapy is a medical technique that involves altering or replacing faulty genes in a person's cells to treat or prevent disease. It is considered a promising area of innovation because it has the potential to provide long-term or even permanent solutions to genetic conditions. For investors, advancements in gene therapy can signal opportunities in biotech companies and emerging treatments with significant growth potential.

warrants financial

"Received gross proceeds of $23.0 million from exercises of Tranche A warrants"

Warrants are special documents that give you the right to buy a company's stock at a set price before a certain date. They are often used as a way for companies to attract investors or raise money, and their value can increase if the company's stock price goes up.

AI-generated analysis. Not financial advice.

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. 05, 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 outlined its strategic outlook for 2026, highlighting anticipated clinical and regulatory milestones across its Revita^® and Rejuva^® programs.

“As we enter 2026, we believe Fractyl is positioned for a definitional year, and our focus is on disciplined execution with an accelerating cadence of clinical and regulatory milestones and progress,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “We are rapidly advancing Revita as an outpatient endoscopic therapy designed to address a root cause of obesity. This year, we expect to deliver pivotal data and potential PMA filing in what we see as the single biggest problem in obesity today: post-GLP-1 weight maintenance. With millions of patients expected to start and then stop taking a GLP-1 this year, we believe weight loss maintenance is the new unmet need in obesity care, and is clearly what patients, prescribers, payers, and the broader health economic community are looking for.”

Revita^®

In 2026, the Company plans to advance Revita through a series of important clinical and regulatory milestones, building on continued progress across the REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal Cohorts as the program moves through pivotal validation in post-GLP-1 weight maintenance. In parallel, Fractyl is aligning clinical development with regulatory strategy and real-world implementation considerations for Revita as the Company advances through a registrational year.

Anticipated 2026 Revita Milestones

• Late January 2026: 6-month randomized data from the REMAIN-1 Midpoint Cohort
• Early 2026: Complete randomizations for the REMAIN-1 Pivotal Cohort
• Q2 2026: 1-year REVEAL-1 Cohort data
• Q3 2026: 1-year REMAIN-1 Midpoint Cohort data
• H2 2026: Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort
• H2 2026: Potential Revita PMA filing in post-GLP-1 weight maintenance

Rejuva^®

Fractyl plans to continue advancing its Rejuva gene therapy platform toward clinical validation in 2026, with progress expected toward first-in-human (FIH) evaluation of its lead program, RJVA-001, in patients with inadequately controlled T2D, subject to regulatory authorization. In H2 2025, Fractyl completed Clinical Trial Applications (CTA) for a RJVA-001 FIH study in EU and Australia, setting the stage for expected dosing of first patients and preliminary data in 2026.

Anticipated 2026 Rejuva Milestones

• Q2 2026: Regulatory feedback on CTA for RJVA-001
• H2 2026: First-in-human dosing of RJVA-001, subject to CTA authorization, and preliminary data

Financial Guidance and Cash Runway

As of December 31, 2025, Fractyl had approximately $81.5 million, in preliminary unaudited cash and cash equivalents. In connection with exercises of Tranche A warrants from Fractyl’s August 2025 financing, an additional $4.1 million of proceeds were received on January 2, 2026, resulting in a balance of $85.6 million in cash and cash equivalents as of such date. Fractyl’s current cash and cash equivalents are expected to fund its operations through early 2027 and support execution across planned 2026 clinical and regulatory milestones.

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’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. The Company has a robust and growing IP portfolio, with 35 granted U.S. patents and approximately 45 pending U.S. applications, along with numerous foreign issued patents and pending applications. Fractyl is based in Burlington, MA. For more information, visit www.fractyl.com.

About Revita^®
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and has completed enrollment.

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 has submitted the first Clinical Trial Application (CTA) module for RJVA-001 in T2D to regulators, and if the CTA is authorized, the Company expects to dose the first patients with RJVA-001 and report preliminary data in H2 2026. RJVA-002, the Company’s second candidate from the Rejuva platform, is a dual GIP/GLP-1 gene therapy for obesity that has demonstrated approximately 30% weight loss in preclinical studies after a single administration, underscoring its potential to deliver durable, well-tolerated metabolic benefits from a one-time intervention.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our anticipated financial performance, including cash and cash equivalents, our expected cash runway, the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any Investigational New Drug (IND)-enabling studies, IND applications or Clinical Trial Applications, communications with regulators, the potential launch or commercialization of any of our product candidates, the potential treatment population or benefits for any of our product candidates, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, redefining the future of metabolic disease treatment, positioning our Company at the forefront of the global opportunity for metabolic care, and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on November 12, 2025 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.

Preliminary Financial Information

The Company’s audited consolidated financial statements at and for the year ended December 31, 2025 are not yet available. As a result, the financial information described in this press release is preliminary and unaudited, represents management’s estimate as of the date hereof and is subject to completion of the Company’s financial closing procedures for the fourth quarter and fiscal year ended December 31, 2025. This preliminary financial information may materially differ from the actual results that will be reflected in the Company’s audited consolidated financial statements when such financial statements are completed and publicly disclosed. The Company’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the Company’s preliminary results.

Contact

Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200

FAQ

When will Fractyl (GUTS) release randomized 6-month REMAIN-1 Midpoint data?

Fractyl expects randomized 6-month REMAIN-1 Midpoint data in late January 2026.

What cash position did Fractyl report on Jan 2, 2026 for GUTS?

Fractyl reported approximately $85.6 million in cash and cash equivalents as of Jan 2, 2026.

What are Fractyl's 2026 milestones for Revita (GUTS)?

Planned milestones include REMAIN-1 pivotal randomization completion in early 2026, REVEAL-1 1-year data in Q2 2026, REMAIN-1 pivotal topline 6-month data in H2 2026, and a potential PMA filing in H2 2026.

Is Fractyl planning a PMA filing for Revita in 2026 (GUTS)?

The company targets a potential Revita PMA filing in H2 2026, contingent on pivotal trial results.

When could Fractyl begin first-in-human dosing for RJVA-001 (GUTS)?

Fractyl expects possible first-in-human dosing of RJVA-001 in H2 2026, subject to regulatory authorization.

How long is Fractyl's current cash runway for GUTS operations?

Fractyl expects current cash and equivalents to fund operations through early 2027.