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Fractyl Health's Revita meets 6-month endpoint in weight study

Fri, 16 Oct 2026 07:01:13 -0400

Fractyl Health, Inc. (Nasdaq: GUTS) announced that its Revita DMR System met a pre-specified six-month co-primary endpoint in the REMAIN-1 pivotal study, a 308-participant, randomized, double-blind, sham-controlled trial evaluating the device for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy.

In the modified intention-to-treat population, participants treated with a single Revita procedure retained approximately 80% of their GLP-1-induced weight loss at six months, compared with 67% for sham participants. Least-squares mean weight regain was 5.1% for Revita versus 8.2% for sham, with a p-value of 0.0023. Additionally, 32% of Revita participants were weight stable or experienced further weight

Fractyl Health's Revita meets 6-month endpoint in weight study

Fri, 16 Oct 2026 07:01:13 -0400

Form 8-K FRACTYL HEALTH, INC. For: Oct 16

Fri, 16 Oct 2026 07:01:00 -0400

si-local-file:///var/storage/secattach/20261016/27195574.html

Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation

Fri, 16 Oct 2026 07:00:00 -0400

REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham

32% of Revita® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)

Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6

Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation

Fri, 16 Oct 2026 07:00:00 -0400

REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham

32% of Revita® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)

Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6

Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation

Fri, 16 Oct 2026 07:00:00 -0400

REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham

32% of Revita^® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)

Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6

Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation

Fri, 16 Oct 2026 07:00:00 -0400

REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham

32% of Revita^® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)

Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6

Form SCHEDULE 13G FRACTYL HEALTH, INC. Filed by: Catalio Capital Management, LP

Tue, 13 Oct 2026 13:48:00 -0400
si-local-file:///var/storage/secattach/20261013/27180454.html

Form 8-K FRACTYL HEALTH, INC. For: Sep 30

Thu, 01 Oct 2026 06:30:00 -0400
si-local-file:///var/storage/secattach/20261001/27131111.html

Form 8-K FRACTYL HEALTH, INC. For: Sep 24

Thu, 24 Sep 2026 16:15:00 -0400
si-local-file:///var/storage/secattach/20260924/27102377.html

Form 4 FRACTYL HEALTH, INC. For: Sep 14 Filed by: BRADLEY WILLIAM

Wed, 16 Sep 2026 16:05:00 -0400
si-local-file:///var/storage/secattach/20260916/27070258.html

Form 8-K FRACTYL HEALTH, INC. For: Sep 10

Fri, 11 Sep 2026 16:15:00 -0400
si-local-file:///var/storage/secattach/20260911/27053055.html

Fractyl Health to Participate in Upcoming September Investor Conferences

Wed, 09 Sep 2026 07:00:00 -0400

BURLINGTON, Mass., Sept. 09, 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 that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will be participating in the following upcoming investor conferences:

H.C. Wainwright 28th Annual Global Investment Conference
Format: On-demand presentation and one-on-one meetings
Presentation available beginning Friday, September 11, 2026 at 7:00 AM ET
One-on-one meetings: Tuesday, September 15, 2026

Morgan Stanley 24th Annual

Fractyl Health to Participate in Upcoming September Investor Conferences

Wed, 09 Sep 2026 07:00:00 -0400

BURLINGTON, Mass., Sept. 09, 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 that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will be participating in the following upcoming investor conferences:

H.C. Wainwright 28th Annual Global Investment Conference
Format: On-demand presentation and one-on-one meetings
Presentation available beginning Friday, September 11, 2026 at 7:00 AM ET
One-on-one meetings: Tuesday, September 15, 2026

Morgan Stanley 24th Annual

Form DEF 14A FRACTYL HEALTH, INC. For: Aug 24

Mon, 24 Aug 2026 16:10:00 -0400
si-local-file:///var/storage/secattach/20260824/26968191.html

Form DEF 14A FRACTYL HEALTH, INC. For: Aug 24

Mon, 24 Aug 2026 16:10:00 -0400
si-local-file:///var/storage/secattach/20260824/26968191.html

Fractyl Health to Host Virtual Commercial Strategy Day on Tuesday, September 1, 2026: The Potential Path to Commercializing Revita®, a Procedural Therapy for Post-GLP-1 Weight Maintenance

Thu, 20 Aug 2026 07:00:00 -0400

BURLINGTON, Mass., Aug. 20, 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 that it will host a virtual Commercial Strategy Day on Tuesday, September 1, 2026 at 11:00 AM ET to discuss the potential commercial opportunity and go-to-market strategy for Revita^®. To register, click here.

The event follows the Company’s positive one-year randomized data from the REMAIN-1 Midpoint Cohort, which showed weight maintenance one year after a

Fractyl Health to Host Virtual Commercial Strategy Day on Tuesday, September 1, 2026: The Potential Path to Commercializing Revita®, a Procedural Therapy for Post-GLP-1 Weight Maintenance

Thu, 20 Aug 2026 07:00:00 -0400

BURLINGTON, Mass., Aug. 20, 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 that it will host a virtual Commercial Strategy Day on Tuesday, September 1, 2026 at 11:00 AM ET to discuss the potential commercial opportunity and go-to-market strategy for Revita^®. To register, click here.

The event follows the Company’s positive one-year randomized data from the REMAIN-1 Midpoint Cohort, which showed weight maintenance one year after a

Form PRE 14A FRACTYL HEALTH, INC. For: Sep 24

Fri, 14 Aug 2026 16:16:00 -0400
si-local-file:///var/storage/secattach/20260814/26930645.html

Form PRE 14A FRACTYL HEALTH, INC. For: Sep 24

Fri, 14 Aug 2026 16:16:00 -0400
si-local-file:///var/storage/secattach/20260814/26930645.html

Fractyl Health, Inc. (GUTS) Tops Q2 EPS by 9c

Mon, 10 Aug 2026 16:50:45 -0400

Fractyl Health, Inc. (NASDAQ: GUTS) reported Q2 EPS of ($0.16), $0.09 better than the analyst estimate of ($0.25).
For earnings history and earnings-related data on Fractyl Health, Inc. (GUTS) click here.

Form 10-Q FRACTYL HEALTH, INC. For: Jun 30

Mon, 10 Aug 2026 16:06:00 -0400
si-local-file:///var/storage/secattach/20260810/26897799.html

Form 10-Q FRACTYL HEALTH, INC. For: Jun 30

Mon, 10 Aug 2026 16:06:00 -0400
si-local-file:///var/storage/secattach/20260810/26897799.html

Form 8-K FRACTYL HEALTH, INC. For: Aug 10

Mon, 10 Aug 2026 16:06:00 -0400
si-local-file:///var/storage/secattach/20260810/26897760.html

Form 8-K FRACTYL HEALTH, INC. For: Aug 10

Mon, 10 Aug 2026 16:06:00 -0400
si-local-file:///var/storage/secattach/20260810/26897760.html