Fractyl Health Completes Randomization in REMAIN-1 Pivotal Cohort of Revita® for Post-GLP-1 Weight Maintenance

Rhea-AI Summary

Fractyl Health (Nasdaq: GUTS) completed randomization in the REMAIN-1 Pivotal Cohort evaluating Revita for weight maintenance after GLP-1 discontinuation. Topline 6-month pivotal data are expected in early Q4 2026, with a potential FDA marketing application in late Q4 2026. The company reiterates cash runway into early 2027.

The randomized, double-blind, sham-controlled study enrolled adults with BMI 30–45 kg/m2 who lost ≥15% body weight on tirzepatide and randomizes 2:1 Revita versus sham; co-primary endpoints target 6-month percent weight regain and 12-month ≥5% responder rate.

Positive

• Randomization complete in REMAIN-1 pivotal cohort
• Topline 6‑month data expected early Q4 2026
• Potential FDA submission targeted late Q4 2026
• Cash runway reiterated into early 2027

Negative

• Regulatory path depends on Q2 2026 FDA feedback on De Novo suitability
• Cash runway limited to early 2027, tight for post-readout activities
• Pivotal endpoints focus on weight regain and 12‑month responder rate, outcome uncertainty remains

Key Figures

Topline pivotal data timing: Early Q4 2026 Potential FDA submission: Late Q4 2026 Cash runway: Into early 2027 +5 more

8 metrics

Topline pivotal data timing Early Q4 2026 Expected 6-month REMAIN-1 pivotal data readout

Potential FDA submission Late Q4 2026 Planned marketing application for post-GLP-1 weight maintenance

Cash runway Into early 2027 Company reiterates funding through pivotal readout

BMI inclusion range BMI ≥30 kg/m2 and ≤45 kg/m2 REMAIN-1 Pivotal Cohort eligibility criteria

Required prior weight loss ≥15% total body weight loss On tirzepatide before GLP-1 discontinuation

Randomization ratio 2:1 (Revita:sham) REMAIN-1 Pivotal Cohort study design

Co-primary endpoint (6 months) Percent total body weight regain Revita vs sham at 6 months

Co-primary endpoint (12 months) ≥5% total body weight loss Proportion maintaining weight loss at 12 months

Market Reality Check

Price: $0.5060 Vol: Volume 3,814,481 is 0.35x...

low vol

$0.5060 Last Close

Volume Volume 3,814,481 is 0.35x the 20-day average of 11,016,822, suggesting a modest participation on the headline. low

Technical Shares at $0.506 are trading below the $1.49 200-day moving average and remain 83.3% under the 52-week high.

Peers on Argus

GUTS gained 4.55% while peers showed mixed moves: ADVM +2.83%, IMMX +2.34%, XFOR...

GUTS gained 4.55% while peers showed mixed moves: ADVM +2.83%, IMMX +2.34%, XFOR +1.47%, ACET +0.54%, ALGS -1.7%. With no peers in the momentum scanner and no same-day peer headlines, action appears stock-specific.

Historical Context

5 past events · Latest: Jan 29 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 29	Clinical data update	Positive	-68.0%	Reported positive 6‑month randomized REMAIN‑1 Midpoint data for Revita.
Jan 06	Management change	Neutral	-2.9%	Appointed new CFO to support commercial-stage preparedness and transition.
Jan 05	Strategic roadmap	Positive	-8.4%	Outlined 2026 clinical and regulatory milestones and reported cash position.
Dec 15	Warrant call	Positive	-3.6%	Called Tranche A warrants after meeting clinical and trading milestones.
Dec 02	Clinical data update	Positive	+17.9%	Reported positive 6‑month REVEAL‑1 open‑label weight maintenance data.

Pattern Detected

Recent positive clinical and strategic updates often saw negative price reactions, with one notable positive reaction to earlier REVEAL-1 data.

Recent Company History

Over the past few months, Fractyl reported multiple positive Revita data sets and strategic updates. On Dec 2, 2025, favorable 6‑month REVEAL‑1 results coincided with a 17.95% gain. However, a warrant call on Dec 15, 2025, a 2026 roadmap on Jan 5, 2026, CFO appointment on Jan 6, 2026, and compelling REMAIN‑1 midpoint data on Jan 29, 2026 all saw negative reactions. Today’s completion of REMAIN‑1 pivotal randomization fits this sequence of advancing the Revita program toward pivotal readout and potential FDA submission in 2026.

Market Pulse Summary

This announcement advanced Revita by completing randomization in the REMAIN‑1 pivotal cohort and fir...

Analysis

This announcement advanced Revita by completing randomization in the REMAIN‑1 pivotal cohort and firming up a path toward a potential FDA marketing application in late Q4 2026. The company reiterated cash runway into early 2027, spanning key milestones like De Novo feedback in Q2 2026 and pivotal 6‑month data in early Q4 2026. Investors may watch enrollment quality, execution on follow-up data readouts, and any FDA feedback that could influence the regulatory pathway.

Key Terms

double-blind, sham-controlled, BMI, GLP-1, +1 more

5 terms

double-blind medical

"REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

sham-controlled medical

"Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita"

A sham-controlled trial compares a real medical procedure or device to a fake version that looks and feels the same but has no therapeutic effect, much like a sugar pill for surgery or implants. For investors, sham control is a sign of rigorous testing because it helps separate true treatment benefits from placebo effects or patient expectations, making clinical results and regulatory prospects more reliable when assessing commercial potential.

BMI medical

"adults with obesity (BMI ≥30 kg/m2 and ≤45 kg/m2) who achieved"

Body mass index (BMI) is a simple number calculated from a person’s weight and height that classifies them as underweight, normal weight, overweight, or obese; think of it as a quick ratio like miles per gallon for body size. Investors watch BMI because shifts in population averages influence demand for healthcare services, drugs, medical devices, and insurance costs, and they can signal longer-term trends in workforce health and public spending.

GLP-1 medical

"weight maintenance following GLP-1 therapy discontinuation"

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.

De Novo pathway regulatory

"FDA feedback on potential for use of the De Novo pathway for Revita."

A de novo pathway is a regulatory route that allows manufacturers to win approval for a novel low- to moderate-risk medical device when there is no previously approved similar product, by showing reasonable assurance of safety and effectiveness. It matters to investors because successful de novo clearance opens a company to an untapped market and can create a first-mover advantage while reducing long-term regulatory uncertainty—like getting a permit to open a new type of store in a neighborhood where none existed before.

AI-generated analysis. Not financial advice.

Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026

Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout

BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced completion of participant randomization in its REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita^® for weight maintenance following GLP-1 therapy discontinuation.

“Completion of randomization in the REMAIN-1 Pivotal Cohort marks an important milestone as we advance Revita toward the definitive clinical evidence we believe will clearly establish its role in post-GLP-1 weight maintenance,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “This study was prospectively designed and statistically powered to demonstrate Revita’s effect. The clinical insights from our REVEAL-1 and REMAIN-1 Midpoint Cohorts, as well as ongoing follow-up from our Germany Real-World Registry study, informed both the study design and our confidence in this program. With randomization now complete and our balance sheet positioned to support us through and beyond the pivotal readout, our focus is on disciplined execution as we prepare to report topline 6-month results in early Q4 2026. We are grateful to the participants, investigators, and clinical site teams whose commitment has made this progress possible.”

Pivotal Study Designed to Deliver Definitive Evidence

The REMAIN-1 Pivotal Cohort is a randomized, double-blind, sham-controlled study evaluating Revita in adults with obesity (BMI ≥30 kg/m² and ≤45 kg/m²) who achieved ≥15% total body weight loss on tirzepatide. Following GLP-1 discontinuation, participants were randomized 2:1 to receive Revita or a sham endoscopic procedure. The co-primary endpoints are percent total body weight regain (Revita vs sham) at 6 months, and proportion of participants maintaining ≥5% total body weight loss at 12 months (responder rate). All participants receive standardized diet and lifestyle counseling throughout the study.

“The level of patient interest we experienced at Baylor was remarkable. We ultimately trained three endoscopists and installed two consoles to perform the Revita procedure to meet demand during the study,” said Mohammed Othman, M.D., Professor of Medicine, Baylor College of Medicine, and a REMAIN-1 Investigator. “Weight regain after GLP-1 discontinuation is a challenge I see regularly in clinical practice, and the enthusiasm from both patients and referring physicians throughout this trial reflects a real and urgent unmet need.”

2026 Revita Clinical and Regulatory Milestones

Fractyl is advancing toward multiple anticipated clinical and regulatory milestones across its REMAIN-1 weight maintenance program, supporting a clear and sequential path toward pivotal readout and potential U.S. regulatory submission:

• Q2 2026: U.S. Food and Drug Administration (FDA) feedback on potential for use of the De Novo pathway for Revita.
• Q2 2026: 1-year REVEAL-1 Cohort data.
• Q3 2026: 1-year REMAIN-1 Midpoint Cohort randomized data.
• Early Q4 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort.
• Late Q4 2026: Potential FDA marketing application submission in post-GLP-1 weight maintenance. The timing and form of submission may be informed by FDA feedback on the potential use of the De Novo pathway for Revita, which is currently expected in Q2 2026.
  

The Company reiterates its previously announced cash runway into early 2027, making it well-positioned to fund operations through key 2026 clinical and regulatory milestones, including the Revita pivotal readout.

About Fractyl Health
Fractyl Health is a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes. The Company’s approach targets organ-level dysfunction to enable durable metabolic control without the burden of chronic therapy. Fractyl is headquartered in Burlington, Massachusetts.

About Revita^®
Revita is Fractyl Health’s lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.

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 are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward- looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding: our anticipated financial performance, including cash and cash equivalents, our expected cash runway, the promise and potential impact of our product candidates, including Revita’s potential for preserving weight loss after GLP-1 drug discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; the potential treatment population or benefits for any of our product candidates or products; our regulatory strategy, including potential use and benefits of the De Novo pathway; our strategic and product development objectives and goals, including with respect to enabling long-term weight maintenance following GLP-1 therapy discontinuation; 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 Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission 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.

Contact

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

FAQ

What does Fractyl (GUTS) announce about REMAIN-1 randomization on Feb 26, 2026?

Fractyl completed participant randomization in the REMAIN-1 pivotal cohort, advancing the Revita program. According to the company, the randomized 2:1 study compares Revita versus a sham procedure in adults who lost ≥15% body weight on tirzepatide, with blinded endpoints at 6 and 12 months.

When will Fractyl (GUTS) report topline REMAIN-1 6-month pivotal results?

Topline 6-month pivotal data are expected in early Q4 2026. According to the company, this readout is the primary near-term milestone guiding potential regulatory submission timing later in Q4 2026.

Could Fractyl (GUTS) submit an FDA marketing application for Revita in 2026?

The company expects a potential FDA marketing application submission in late Q4 2026. According to the company, submission timing may be informed by anticipated Q2 2026 FDA feedback on use of the De Novo pathway for Revita.

What are the REMAIN-1 co-primary endpoints investors should watch for (GUTS)?

The co-primary endpoints are percent total body weight regain at 6 months and proportion maintaining ≥5% weight loss at 12 months. According to the company, both endpoints measure Revita versus sham after GLP-1 discontinuation.

How long is Fractyl (GUTS) funded to operate through 2026–2027?

Fractyl reiterates cash runway into early 2027 to support key 2026 milestones. According to the company, available funds are positioned to cover operations through the pivotal readout and related regulatory activities.