Fractyl Health

GUTS

Market cap $76.5M

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 therapy discontinuation.

The heavy selling pressure might have exhausted for Fractyl Health, Inc. (GUTS) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Fractyl Health offers a buy-the-dip opportunity after an overreaction to underwhelming 6-month pilot data for its Revita device. Revita's pivotal Phase 3 obesity trial is well-funded, with topline results expected in 2H 2026 and a low statistical bar for success. Weight regain in the Revita arm was driven by a single site; excluding it, results align with prior positive data, supporting optimism for pivotal readout.

LOS ANGELES--(BUSINESS WIRE)--Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTS.

LOS ANGELES--(BUSINESS WIRE)--Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTS.

Fractyl Health Inc. (NASDAQ: GUTS) stock plunged on Thursday after the company hinted at a change in its U.S. regulatory strategy for Revita.

Fractyl Health, Inc. (GUTS) Discusses REMAIN-1 Midpoint Cohort Results on Revita for Weight Maintenance After GLP-1 Discontinuation Transcript

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

BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026.

Randomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 Approximately $85.6 million in cash and cash equivalents on hand, supporting execution across planned 2026 milestones Received gross proceeds of $23.0 million from exercises of Tranche A warrants from August 2025 financing, with cash runway into early 2027 BURLINGTON, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today outlined its strategic outlook for 2026, highlighting anticipated clinical and regulatory milestones across its Revita ® and Rejuva ® programs.