Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026
Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026
Reports new post-hoc analyses from REMAIN-1 Midpoint Cohort showing statistically significant ablation-length (i.e., dose)-dependent treatment effect on post-GLP-1 weight maintenance at 6 months
Patients with greater GLP-1-induced weight loss prior to randomization also exhibited larger sham-adjusted treatment effects at 6 months, with effect size increasing over time
New analyses provide further support for Revita mechanism of action and REMAIN-1 Pivotal Cohort design
Reiterates cash runway guidance into early 2027, beyond anticipated Pivotal data readout
Conference call today at 4:30 p.m. ET
BURLINGTON, Mass., March 24, 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 (T2D), today announced fourth quarter and full year 2025 financial results and provided business updates. The Company also reported new post-hoc analyses from the REMAIN-1 Midpoint Cohort showing a statistically significant ablation length (i.e., dose)-dependent treatment effect on post GLP-1 weight maintenance at 6 months that further strengthens the Company's belief in the REMAIN-1 Pivotal Cohort, with topline 6-month randomized data expected in early Q4 2026 and, if positive, potential De Novo marketing application submission expected in late Q4 2026.
"Completion of randomization in the REMAIN-1 Midpoint and Pivotal Cohorts marks a critical execution milestone, and today's new analyses from the Midpoint Cohort 6-month data gives us even greater anticipation for what the pivotal study might show. Revita$(R)$ is a procedural therapy that appears to work very much like a drug: the effect of weight maintenance is larger in patients with greater GLP-1 weight loss and in those who receive longer lengths of duodenal ablation. The REMAIN-1 Pivotal Cohort was prospectively designed and statistically powered to demonstrate Revita's effect across these dimensions," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "Approximately 30 million patients are projected to be on GLP-1s by 2035. The majority will face discontinuation and significant weight regain. Fractyl stands alone developing the first potential procedural option for post-GLP-1 weight maintenance with pivotal data expected this year."
New Post-Hoc Analyses from REMAIN-1 Midpoint Cohort Demonstrating Dose-Dependent Treatment Effect at 6 months, Providing Further Confidence in REMAIN-1 Pivotal Cohort Design
Fractyl is reporting 6-month results from new post-hoc analyses of the REMAIN-1 Midpoint Cohort evaluating the relationship between treatment effect, procedural dose (defined as length of duodenal ablation) and degree of GLP-1-induced weight loss prior to Revita treatment. The analyses demonstrate that Revita's treatment effect is ablation length (i.e., dose)-dependent and greatest in participants with longer ablation length and higher run-in weight loss, consistent with the biological rationale for Revita and analogous to the dose-response relationships observed with drugs.
Key findings from the post-hoc analyses (N=45) include:
-- A statistically significant correlation between ablation length and
weight maintenance in the Revita arm demonstrates that more complete
duodenal ablation drives greater treatment effect (n=29; p=0.048),
reinforcing the view that the duodenal mucosa is a compelling target.
-- Among participants with above median GLP-1-induced weight loss, the study
observed a 70% reduction in weight regain with widening separation from
sham from 1 to 6 months (p=0.004), providing supportive evidence for a
potentially substantial clinically meaningful effect size over time in a
large patient population. These results are consistent with the view that
patients at greatest need may derive the greatest benefit from Revita.
-- In participants with above median GLP-1-induced weight loss who received
greater than 14 cm duodenal ablation, Revita participants retained 88% of
GLP-1 induced weight loss at six months compared to only 60% in sham
participants.
Blinded operational data from the Pivotal Cohort confirm that mean and median ablation length was 16 cm and mean total body weight loss was 18.3%, placing the Pivotal Cohort squarely within the optimal treatment zone identified in the Midpoint post-hoc analysis. Taken together, these data further support the design and statistical analysis of the REMAIN-1 Pivotal Cohort and reinforce the Company's confidence in the ongoing pivotal study's ability to demonstrate a clinically meaningful and lasting treatment effect.
Select Recent Revita(R) Clinical Highlights
The Company is studying Revita in the REMAIN-1 weight maintenance program, which is designed to evaluate Revita's potential to maintain weight loss following GLP-1 based therapy discontinuation. The REMAIN-1 program includes three distinct participant cohorts that are conducted under a single IDE: the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort.
The following highlights represent key clinical milestones from the Germany Real-World Registry study and across the REMAIN-1 program. For complete data disclosures, please refer to the Company's previously issued press releases and SEC disclosures, available at ir.fractyl.com.
-- In November 2025, Fractyl reported 2-year data from the Germany
Real-World Registry study showing that a single Revita procedure led to
an average 8.9% total body weight loss and a 1.7% reduction in HbA1c in
participants with obesity and advanced T2D with no device- or
procedure-related serious adverse events reported to date.
-- In December 2025, Fractyl reported positive 6-month REVEAL-1 Cohort
open-label results showing sustained post-GLP-1 weight maintenance after
a single Revita procedure. Participants who lost 24% total body weight
(>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1
discontinuation and a single Revita treatment, with a 1.5% mean weight
change observed with Revita (n=17), compared to 10% weight regain at
similar time points reported in published third-party studies after GLP-1
withdrawal alone.
-- In January 2026, Fractyl announced compelling 6-month randomized REMAIN-1
Midpoint data showing durable weight maintenance with Revita after GLP-1
discontinuation. Participants with above median GLP-1-associated weight
loss experienced approximately 70% less post-GLP-1 weight regain with
Revita versus sham at 6 months. These pilot study results support the
pivotal study design and further substantiate Revita's potential to be
the first durable procedural therapy for post-GLP-1 weight maintenance.
-- In February 2026, Fractyl completed participant randomization in the
REMAIN-1 Pivotal Cohort.
Fractyl Forward: Anticipated 2026 Revita Milestones
With randomization complete, Fractyl is advancing toward multiple anticipated clinical and regulatory milestones toward pivotal readout and potential U.S. regulatory submission. The Company reiterates its previously announced cash runway into early 2027, beyond the anticipated pivotal data readout.
In connection with its regulatory strategy, the Company received pre-submission feedback from the U.S. Food and Drug Administration (FDA), in which it acknowledged that the safety profile of the Revita DMR System, based on clinical data from over 300 procedures, is consistent with a Class II device classification. As in all applications, the FDA indicated that final pathway determinations will be made following review of the complete safety dataset, which the Company intends to include in its potential De Novo marketing application submission.
-- 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 De Novo marketing application submission in
post-GLP-1 weight maintenance.
Select Recent Rejuva(R) Development Progress
Rejuva is Fractyl's gene therapy platform designed to achieve long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones. The lead product candidate, RJVA-001, is being advanced for patients with inadequately controlled T2D. The second candidate, RJVA-002, is a dual GIP/GLP-1 gene therapy designed to treat obesity.
-- In October 2025, Fractyl announced potent new preclinical data from
RJVA-002, its dual GIP/GLP-1 Smart GLP-1$(TM)$ gene therapy candidate for
obesity, showing approximately 30% weight loss after a single
administration in a translational obesity model, with no observed adverse
effects.
-- In the second half of 2025, Fractyl submitted Clinical Trial Applications
(CTAs) for RJVA-001 in T2D to regulators in the EU (Netherlands) and
Australia, advancing the program toward its anticipated first-in-human
study.
Fractyl Forward: Anticipated 2026 Rejuva Milestones
-- Q2 2026: Regulatory feedback on CTAs for RJVA-001.
-- H2 2026: First-in-human dosing of RJVA-001, subject to CTA authorization,
and expected reporting of preliminary data.
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