FRACTYL HEALTH (GUTS) Company Report

Fractyl Health announced positive six-month randomized results from the REMAIN-1 Midpoint Cohort for Revita®, demonstrating durable weight maintenance after GLP-1 discontinuation.
Revita-treated patients experienced 4.5% weight regain versus 7.5% in the sham arm at 6 months; an exploratory analysis showed approximately 70% less post-GLP-1 weight regain with Revita versus sham in patients with above median GLP-1-associated weight loss.
The company reported favorable safety and tolerability for Revita through six months, with no treatment-emergent serious adverse events related to the device or procedure.
Fractyl has requested FDA feedback on reclassifying Revita under the De Novo pathway, with a decision expected in Q2 2026, which could lead to a more efficient regulatory review process.
Key upcoming milestones in 2026 include completing randomizations in the REMAIN-1 Pivotal Cohort in February, 1-year data from REVEAL-1 and REMAIN-1 Midpoint Cohort in Q2 and Q3, respectively, and potential FDA submission in H2 2026.

7 days ago

8-K

FRACTYL health Reports Positive 6-Month REMAIN-1 Midpoint Cohort Data and Provides Regulatory Update

GUTS

Guidance Update

Product Launch

New Projects/Investments

FRACTYL health announced positive 6-month randomized data from its REMAIN-1 Midpoint Cohort for Revita, showing patients with greater GLP-1-associated weight loss experienced approximately 70% less post-GLP-1 weight regain with Revita vs sham at 6 months (p=0.004, one-sided).
The company reported excellent safety and tolerability through 6 months, with no new related Treatment-Emergent Adverse Events between 3-month and 6-month follow-up.
FRACTYL health has requested to reclassify Revita under the De Novo pathway for US regulatory strategy, with FDA feedback expected in Q2 2026.
The REMAIN-1 pivotal cohort is fully enrolled and proceeding ahead of schedule, with randomizations expected to be completed in February 2026 and 6-month primary endpoint data anticipated in H2 2026, potentially leading to an FDA submission in H2 2026.

7 days ago

Presentation

Fractyl Health Presents Positive Six-Month REMAIN-1 Midpoint Cohort Data

GUTS

Product Launch

New Projects/Investments

Fractyl Health announced positive six-month data from its REMAIN-1 midpoint cohort pilot study, showing that Revita continued to demonstrate weight maintenance six months after GLP-1 discontinuation.
In patients with greater GLP-1-associated run-in weight loss, Revita reduced post-GLP-1 weight regain by approximately 70% versus sham at six months, with a p-value of 0.004.
The company has requested FDA feedback on reclassifying Revita under the De Novo classification pathway for a potentially more efficient regulatory review process, with feedback expected in Q2 2026.
The pivotal cohort study is fully enrolled, with randomization expected to complete in February, and top-line pivotal data and potential FDA filing anticipated in the second half of 2026.

7 days ago

Transcript

Fractyl Health Reports Positive Six-Month REMAIN-1 Midpoint Cohort Data and Provides Regulatory Update

GUTS

Product Launch

New Projects/Investments

Guidance Update

Fractyl Health reported positive six-month data from its REMAIN-1 midpoint cohort pilot study, demonstrating weight maintenance for Revita after GLP-1 discontinuation.
In the full efficacy population, Revita-treated patients regained 4.5% of body weight compared to 7.5% in the sham arm. For patients with above-average GLP-1 induced weight loss, Revita reduced post-GLP-1 weight regain by approximately 70% versus sham.
The company expects FDA feedback in Q2 2026 on reclassifying Revita under the De Novo pathway.
Top-line pivotal data and potential FDA filing are anticipated in the second half of 2026.

7 days ago

Transcript

Fractyl Health Presents Positive Six-Month Revita Data and Provides Regulatory Update

GUTS

Product Launch

New Projects/Investments

Guidance Update

Fractyl Health announced positive six-month data from its REMAIN-1 midpoint cohort pilot study for Revita, demonstrating sustained weight maintenance after GLP-1 discontinuation.
In patients with greater GLP-1-associated weight loss, Revita showed a 70% reduction in post-GLP-1 weight regain versus sham at six months.
The company has requested FDA feedback on reclassifying Revita under the De Novo pathway, with a decision expected in Q2 2026.
The pivotal study is fully enrolled and on track for top-line data and potential FDA filing in the second half of 2026.

7 days ago

Transcript

Fractyl Health Updates Cash Position and Outlines 2026 Milestones

GUTS

Guidance Update

New Projects/Investments

Fractyl Health reported preliminary unaudited cash and cash equivalents of approximately $81.5 million as of December 31, 2025, which increased to $85.6 million by January 2, 2026, and is expected to fund operations through early 2027.
For its Revita program, the company anticipates key milestones in 2026, including 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026 and a potential Revita PMA filing in post-GLP-1 weight maintenance in H2 2026.
The Rejuva gene therapy platform is expected to receive regulatory feedback on the Clinical Trial Application (CTA) for RJVA-001 in Q2 2026, with first-in-human dosing and preliminary data anticipated in H2 2026.

Jan 5, 2026, 12:05 PM

8-K

Fractyl Provides Clinical Data Update for Revita in Post-GLP-1 Weight Maintenance

GUTS

New Projects/Investments

Product Launch

Guidance Update

Fractyl's Revita is an outpatient endoscopic treatment targeting post-GLP-1 weight rebound.
Recent Reveal-1 open-label data in 17 patients showed an average regain of only 1.5% of total body weight at six months after stopping GLP-1s, compared to an expected 10%+ regain.
The company expects to release six-month randomized data from 45 patients in January.
The pivotal Remain-1 study (315 patients) is fully enrolled, with six-month data expected in the second half of 2026, leading to an FDA filing for approval in the post-GLP-1 obesity setting.
Revita has Breakthrough Device Designation from the FDA, which could lead to an accelerated approval process, potentially within nine months for positive pivotal data.

Dec 3, 2025, 6:45 PM

Transcript

Fractyl Health Presents Positive Revita Data for Post-GLP-1 Weight Maintenance

GUTS

New Projects/Investments

Product Launch

Guidance Update

Fractyl Health (GUTS) is developing Revita, an endoscopic treatment designed to prevent post-GLP-1 weight rebound, a challenge faced by an estimated 6 million people annually who discontinue GLP-1 medications.
Recent Reveal-1 open-label data from 17 patients at six months showed that Revita patients regained only 1.5% of total body weight after stopping GLP-1s, significantly less than the expected 10%+ regain, and maintained stable glucose control with an HbA1c change of 0.04%.
The Remain-1 Midpoint pilot study (45 patients) demonstrated a 10-kilogram difference in weight change at three months, with the Revita arm losing 2 kilograms and the sham arm regaining 8 kilograms after GLP-1 discontinuation.
Key upcoming catalysts include six-month randomized data from the Remain-1 Midpoint study in January, followed by full pivotal data from the 315-patient Remain study in the second half of 2026.
Revita has received Breakthrough Device Designation from the FDA, which could lead to an accelerated review process, with approvals for such devices typically taking about nine months after positive pivotal data.

Dec 3, 2025, 6:45 PM

Transcript

Fractyl Health Reports Positive 6-Month REVEAL-1 Study Results

GUTS

New Projects/Investments

Fractyl Health, Inc. announced positive 6-month results from its open-label REVEAL-1 Cohort for its Revita procedure, demonstrating sustained weight maintenance after GLP-1 discontinuation.
Participants who received a single Revita procedure showed a mean total body weight change of 1.5% \u00b1 1.3% at 6 months, in contrast to approximately 10% weight regain typically observed in third-party studies after GLP-1 withdrawal alone.
The study also reported minimal change in HbA1c levels (0.04% \u00b1 0.08%) and excellent tolerability, with no procedure-related serious adverse events.
The company anticipates several key clinical readouts in 2026, including 6-month randomized data from the REMAIN-1 Midpoint Cohort in January 2026 and a potential Revita PMA filing in H2 2026.

Dec 2, 2025, 12:05 PM

8-K

Fractyl Health Reports Q3 2025 Financials and Advances Clinical Programs

GUTS

Earnings

Guidance Update

New Projects/Investments

Fractyl Health reported a net loss of $45.6 million for Q3 2025, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants.
As of September 30, 2025, the company held $77.7 million in cash and cash equivalents, with a cash runway projected to extend into early 2027, funding key milestones.
The company announced positive three-month data from the Remain One Midpoint cohort, where Revita-treated patients lost an additional 2.5% of total body weight after GLP-1 discontinuation, contrasting with a 10% regain in the sham group.
Enrollment for the Remain One pivotal cohort was completed in Q2 2025, with over 60% of patients randomized by October 31st, and full randomization anticipated in early 2026.
Key upcoming catalysts include six-month data from Reveal One in Q4 2025, six-month randomized data from Remain One Midpoint in Q1 2026, and top-line pivotal data and potential PMA submission in H2 2026.