StreetInsider.com News Articles

Form 8-K FRACTYL HEALTH, INC. For: Feb 26

Thu, 26 Feb 2026 07:06:00 -0500

si-local-file:///var/storage/secattach/20260226/26064273.html

Form 8-K FRACTYL HEALTH, INC. For: Feb 26

Thu, 26 Feb 2026 07:06:00 -0500

si-local-file:///var/storage/secattach/20260226/26064273.html

Fractyl Health completes enrollment in weight maintenance study

Thu, 26 Feb 2026 07:02:04 -0500

Fractyl Health Inc. (NASDAQ: GUTS) announced completion of participant randomization in its REMAIN-1 Pivotal Cohort study, evaluating the Revita device for weight maintenance following GLP-1 therapy discontinuation.

The randomized, double-blind, sham-controlled study enrolled adults with obesity who achieved at least 15% total body weight loss on tirzepatide. Participants were randomized 2:1 to receive Revita or a sham endoscopic procedure after discontinuing GLP-1 therapy.

The study's co-primary endpoints are percent total body weight regain at 6 months and the proportion of participants maintaining at least 5% total body weight loss at 12 months. Fractyl expects to report topline 6-month results in early fourth

Fractyl Health completes enrollment in weight maintenance study

Thu, 26 Feb 2026 07:02:04 -0500

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

Thu, 26 Feb 2026 07:00:00 -0500

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

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

Thu, 26 Feb 2026 07:00:00 -0500

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

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Alyeska Investment Group, L.P.

Tue, 17 Feb 2026 16:40:00 -0500

si-local-file:///var/storage/secattach/20260217/26014212.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Alyeska Investment Group, L.P.

Tue, 17 Feb 2026 16:40:00 -0500

si-local-file:///var/storage/secattach/20260217/26014212.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Mithril LP

Thu, 12 Feb 2026 16:19:00 -0500

si-local-file:///var/storage/secattach/20260212/25992216.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Mithril LP

Thu, 12 Feb 2026 16:19:00 -0500

si-local-file:///var/storage/secattach/20260212/25992216.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: HCC Manager LLC

Wed, 04 Feb 2026 13:41:00 -0500

si-local-file:///var/storage/secattach/20260204/25945830.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: HCC Manager LLC

Wed, 04 Feb 2026 13:41:00 -0500

si-local-file:///var/storage/secattach/20260204/25945830.html

Morgan Stanley Downgrades Fractyl Health Inc (GUTS) to Equalweight

Thu, 29 Jan 2026 16:25:33 -0500

Morgan Stanley analyst Michael E Ulz downgraded Fractyl Health Inc (NASDAQ: GUTS) from Overweight to Equalweight with a price target of $2.00 (from $8.00).

The analyst comments "Randomized 6mo results for Revita in weight maintenance showed trends, but fell short of expectations, raising questions. While we continue to believe success in the pivotal study is possible (data 2H26), we take a more cautious view on the potential of Revita and move to the sidelines."

For an analyst ratings summary and ratings history on Fractyl Health Inc click here. For more ratings news on Fractyl Health Inc click here.

Shares of Fractyl

Morgan Stanley Downgrades Fractyl Health Inc (GUTS) to Equalweight

Thu, 29 Jan 2026 16:25:33 -0500

Morgan Stanley analyst Michael E Ulz downgraded Fractyl Health Inc (NASDAQ: GUTS) from Overweight to Equalweight with a price target of $2.00 (from $8.00).

For an analyst ratings summary and ratings history on Fractyl Health Inc click here. For more ratings news on Fractyl Health Inc click here.

Shares of Fractyl

Morgan Stanley Downgrades Fractyl Health Inc (GUTS) to Equalweight

Thu, 29 Jan 2026 16:25:33 -0500

Morgan Stanley analyst Michael E Ulz downgraded Fractyl Health Inc (NASDAQ: GUTS) from Overweight to Equalweight with a price target of $2.00 (from $8.00).

For an analyst ratings summary and ratings history on Fractyl Health Inc click here. For more ratings news on Fractyl Health Inc click here.

Shares of Fractyl

Form 8-K FRACTYL HEALTH, INC. For: Jan 29

Thu, 29 Jan 2026 08:01:00 -0500

si-local-file:///var/storage/secattach/20260129/25912503.html

Form 8-K FRACTYL HEALTH, INC. For: Jan 29

Thu, 29 Jan 2026 08:01:00 -0500

si-local-file:///var/storage/secattach/20260129/25912503.html

Fractyl Health reports weight maintenance data for Revita therapy

Thu, 29 Jan 2026 07:02:36 -0500

Fractyl Health Inc. (NASDAQ: GUTS) announced six-month results from its REMAIN-1 Midpoint Cohort study evaluating Revita for weight maintenance after GLP-1 drug discontinuation. The blinded, sham-controlled study showed Revita-treated patients experienced 4.5% weight regain compared to 7.5% in the sham group at six months.

In an exploratory analysis of patients who achieved above median weight loss during GLP-1 treatment, Revita participants experienced 4.2% weight regain versus 13.3% with sham treatment, representing approximately 70% less post-GLP-1 weight regain. The study included 40 participants in the prespecified efficacy population, with five excluded due to diet and lifestyle noncompliance.

Revita-treated patients demonstrated improvements in cardiometabolic

Fractyl Health reports weight maintenance data for Revita therapy

Thu, 29 Jan 2026 07:02:36 -0500

Revita-treated patients demonstrated improvements in cardiometabolic

Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation

Thu, 29 Jan 2026 07:00:00 -0500

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability

Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months

Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026

Based on ongoing interactions and favorable safety data to date, the Company has requested

Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation

Thu, 29 Jan 2026 07:00:00 -0500

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability

Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months

Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026

Based on ongoing interactions and favorable safety data to date, the Company has requested

Form 4 FRACTYL HEALTH, INC. For: Jan 12 Filed by: Smith Weber Lara

Wed, 14 Jan 2026 16:30:00 -0500
si-local-file:///var/storage/secattach/20260114/25850325.html

Form 4 FRACTYL HEALTH, INC. For: Jan 12 Filed by: Smith Weber Lara

Wed, 14 Jan 2026 16:30:00 -0500
si-local-file:///var/storage/secattach/20260114/25850325.html

Form 3 FRACTYL HEALTH, INC. For: Jan 12 Filed by: Smith Weber Lara

Wed, 14 Jan 2026 16:15:00 -0500
si-local-file:///var/storage/secattach/20260114/25850158.html

Form 3 FRACTYL HEALTH, INC. For: Jan 12 Filed by: Smith Weber Lara

Wed, 14 Jan 2026 16:15:00 -0500
si-local-file:///var/storage/secattach/20260114/25850158.html