StreetInsider.com News Articles

Fractyl Health cuts 45% of workforce, focuses on Revita device

Thu, 22 Oct 2026 07:17:56 -0400

Fractyl Health, Inc. (Nasdaq: GUTS) announced it is concentrating resources on its lead product candidate, Revita, following positive six-month results from its REMAIN-1 pivotal trial, while discontinuing internal development of its Rejuva gene therapy program.

The Burlington, Massachusetts-based company said the REMAIN-1 Pivotal Cohort met its prespecified six-month co-primary endpoint, showing statistically significant results in weight regain compared to sham (p=0.0023). Revita is an endoscopic procedure designed to remodel the duodenal lining in patients who have discontinued GLP-1 therapies.

As part of the restructuring, Fractyl will reduce its workforce by approximately 45%, with the cuts expected to be substantially complete by November

Form 8-K FRACTYL HEALTH, INC. For: Oct 21

Thu, 22 Oct 2026 07:01:00 -0400

si-local-file:///var/storage/secattach/20261022/27218801.html

Fractyl Health Sharpens Focus on Revita Following Positive Pivotal Results, Advancing Toward Planned FDA De Novo Submission in Post-GLP-1 Weight Maintenance

Thu, 22 Oct 2026 07:00:00 -0400

Following positive topline six-month REMAIN-1 pivotal results, Revita advancing toward planned FDA De Novo submission in late Q4 2026 and anticipated 12-month pivotal data readout in Q1 2027

Workforce reduction aligns organization behind Revita's near-term clinical and commercial opportunity

Company discontinuing development of Rejuva candidates and seeking strategic alternatives to maximize the value of its Rejuva gene therapy program

Cash runway extended into Q2 2027; quarterly operating cash burn expected to be reduced by ~50% to approximately $8 million by end of Q2 2027

Fractyl Health Sharpens Focus on Revita Following Positive Pivotal Results, Advancing Toward Planned FDA De Novo Submission in Post-GLP-1 Weight Maintenance

Thu, 22 Oct 2026 07:00:00 -0400

Following positive topline six-month REMAIN-1 pivotal results, Revita advancing toward planned FDA De Novo submission in late Q4 2026 and anticipated 12-month pivotal data readout in Q1 2027

Workforce reduction aligns organization behind Revita's near-term clinical and commercial opportunity

Company discontinuing development of Rejuva candidates and seeking strategic alternatives to maximize the value of its Rejuva gene therapy program

Cash runway extended into Q2 2027; quarterly operating cash burn expected to be reduced by ~50% to approximately $8 million by end of Q2 2027

Fractyl Health Inc (GUTS) PT Lowered to $39 at Canaccord

Tue, 20 Oct 2026 06:47:58 -0400

(Updated - October 20, 2026 6:47 AM EDT)

Canaccord analyst Whitney Ijem lowered the price target on Fractyl Health Inc (NASDAQ: GUTS) to $39.00 (from $96.00) while maintaining a Buy rating.

The analyst commented: "Last week GUTS shared 6mo Revita pivotal data (webcast replay here, presentation here) that demonstrated an LS mean 80% weight loss maintained at 6mo vs. 68% with the sham procedure (p=0.0023), meaning the one-time procedure reduced the amount of weight regained after stopping tirzepatide by ~40%. 32% of patients didn't regain any weight at all or kept losing. Weight maintenance is a hot topic these days - as

Fractyl Health Inc (GUTS) PT Lowered to $39 at Canaccord

Tue, 20 Oct 2026 06:47:58 -0400

(Updated - October 20, 2026 6:47 AM EDT)

Canaccord analyst Whitney Ijem lowered the price target on Fractyl Health Inc (NASDAQ: GUTS) to $39.00 (from $96.00) while maintaining a Buy rating.

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Fractyl Health, Inc. to Contact Law Firm

Mon, 19 Oct 2026 19:18:00 -0400

Fractyl Health, Inc. (NASDAQ: GUTS) shareholders should email fletcher@fmoorelaw.com

NEW YORK, Oct. 19, 2026 /PRNewswire/ --

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Fractyl Health, Inc. to Contact Law Firm

Mon, 19 Oct 2026 19:18:00 -0400

Fractyl Health, Inc. (NASDAQ: GUTS) shareholders should email fletcher@fmoorelaw.com

NEW YORK, Oct. 19, 2026 /PRNewswire/ --

Fractyl Health Inc (GUTS) PT Lowered to $5 at Craig-Hallum

Mon, 19 Oct 2026 08:49:59 -0400

Craig-Hallum analyst Chase Knickerbocker lowered the price target on Fractyl Health Inc (NASDAQ: GUTS) to $5.00 (from $48.00) while maintaining a Buy rating.

Fractyl Health Inc (GUTS) PT Lowered to $4 at Morgan Stanley

Mon, 19 Oct 2026 08:31:36 -0400

Morgan Stanley analyst Michael E Ulz lowered the price target on Fractyl Health Inc (NASDAQ: GUTS) to $4.00 (from $24.00) while maintaining a Equalweight rating.

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
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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
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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