Fractyl Health, INC 8-K filings

Fractyl Health announced one-year results from its REMAIN-1 Midpoint Cohort, showing its Revita DMR System maintained significant weight loss after GLP-1 discontinuation.

Fractyl Health, Inc. successfully concluded its 2026 Annual Meeting of Stockholders, confirming the election of three Class II directors and the ratification of its independent auditors.

Fractyl Health announces positive one-year results from its REVEAL-1 study, showing sustained weight maintenance after a single Revita procedure post-GLP-1 therapy.

Fractyl Health announced first quarter 2026 financial results, reiterating key clinical and regulatory milestones for its Revita and Rejuva platforms, and maintaining cash runway guidance into early 2027.

Fractyl Health announced authorization in the Netherlands to begin a Phase 1/2 human study for RJVA-001, a novel gene therapy targeting type 2 diabetes, marking a significant step towards a dual clinical-stage company.

Fractyl Health announced Q4 and full-year 2025 financial results, highlighted positive Revita clinical data, and reiterated its cash runway into early 2027.

Fractyl Health, Inc. received a Nasdaq notice for non-compliance with the minimum bid price rule, risking delisting if not resolved by September 9, 2026.

Fractyl Health announced the completion of participant randomization in its REMAIN-1 Pivotal Cohort for Revita, targeting post-GLP-1 weight maintenance, with key data and regulatory milestones expected in 2026.

Fractyl Health announced positive 6-month interim results from its REMAIN-1 Midpoint Cohort, demonstrating Revita's potential for sustained weight maintenance after GLP-1 discontinuation and progress in its US regulatory strategy.

Fractyl Health, a metabolic therapeutics company, announced the appointment of Lara Smith Weber as its new Chief Financial Officer, effective January 12, 2026, replacing Lisa Davidson.

Fractyl Health outlines its strategic outlook for 2026, detailing clinical and regulatory milestones for Revita and Rejuva programs, supported by an $85.6 million cash runway into early 2027.

Fractyl Health announced it will call its Tranche A Warrants for cancellation, offering holders the option to exercise at $1.05 per share, potentially raising $17.9 million.

Fractyl Health announced positive 6-month data from its REVEAL-1 study, demonstrating Revita's potential for sustained weight and metabolic maintenance after GLP-1 drug discontinuation.

Fractyl Health announced third quarter 2025 financial results and business updates, highlighting positive Revita clinical data and an extended cash runway into early 2027.

Fractyl Health, Inc. stockholders approved the issuance of common stock related to warrants from a recent financing transaction at a Special Meeting held on October 3, 2025.

Fractyl Health, Inc. announced the pricing of an underwritten public offering of 60 million shares of common stock at $1.00 per share, expecting to raise approximately $56.0 million in net proceeds to fund operations into early 2027.

Fractyl Health announced positive 3-month interim results from its REMAIN-1 Midpoint Cohort, demonstrating Revita's potential to maintain weight loss after GLP-1 discontinuation.

Fractyl Health, Inc. announced the appointment of Christopher Thompson, M.D. and Ian Sheffield to its Board of Directors, with Mr. Sheffield also joining the Audit Committee, alongside the resignation of Amy W. Schulman.

Fractyl Health reports Q2 2025 financial results, positive clinical data for Revita, and a $23 million public offering to extend cash runway.

Fractyl Health, Inc. completed an underwritten public offering of common stock and warrants, securing approximately $20.7 million in net proceeds to fund pipeline programs and operations.

Fractyl Health, Inc. announced positive 3-month data from its Revita REMAIN-1 pivotal study, showing sustained weight loss after GLP-1 discontinuation, alongside promising preclinical data for its Rejuva gene therapy platform for obesity and type 2 diabetes.

Fractyl Health, Inc. announced the issuance of two new U.S. patents, significantly strengthening its intellectual property portfolio for duodenal resurfacing innovations aimed at treating metabolic diseases.

Fractyl Health, Inc. announced that its stockholders re-elected three Class I directors and ratified Ernst & Young LLP as its independent auditors for the fiscal year ending December 31, 2025, at the Annual Meeting held on June 11, 2025.

Fractyl Health has submitted the first module of its Clinical Trial Application in Europe for RJVA-001, a gene therapy candidate for type 2 diabetes.

Fractyl Health's Rejuva smart GLP-1 gene therapy platform shows potential for durable metabolic improvements and a favorable safety profile in preclinical studies, paving the way for first-in-human trials.

Fractyl Health reports first quarter 2025 financial results and provides business updates, highlighting clinical and operational momentum with its Revita and Rejuva programs.

Fractyl Health reports promising early data suggesting its Revita procedure may help patients maintain weight loss after stopping GLP-1 drugs, addressing a significant unmet need.

Fractyl Health, Inc. announces the date for its 2025 annual meeting of stockholders as June 11, 2025.

Fractyl Health reports financial results and business updates, emphasizing strong demand for its REMAIN-1 study and plans for Rejuva's clinical trial application.

Fractyl Health is shifting its focus to weight maintenance solutions and gene therapy, pausing investment in its type 2 diabetes programs and reducing its workforce by 17%.