Every 8-K that Fractyl Health (GUTS) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow GUTS and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full GUTS filings page.
Fractyl Health, Inc. reported second quarter 2026 results and clinical progress for its obesity and type 2 diabetes programs. For the quarter ended June 30, 2026, research and development expenses were $13.8 million versus $21.2 million a year earlier, and selling, general and administrative expenses were $5.3 million versus $4.9 million. Net loss was $25.5 million compared with $27.9 million, while Adjusted EBITDA was a loss of $16.3 million versus a $24.0 million loss.
As of June 30, 2026, Fractyl held $47.1 million in cash and cash equivalents and expects this to fund operations into early 2027. The balance sheet showed total assets of $82.0 million and a stockholders’ equity deficit of $1.7 million.
Clinically, one-year randomized REMAIN-1 Midpoint Cohort data showed Revita-treated patients in an optimized subgroup maintained about 84% of prior GLP-1-induced weight loss versus 46% with sham, with no device- or procedure-related serious adverse events through one year. Open-label REVEAL-1 data showed maintenance of roughly 78% of GLP-1-induced weight loss. The REMAIN-1 Pivotal Cohort six-month topline readout is expected in early Q4 2026, with a potential FDA De Novo submission in late Q4 2026. Rejuva gene therapy candidate RJVA-001 received Clinical Trial Authorization in the Netherlands and ethics approval in Australia, with first-in-human dosing and preliminary data targeted for the second half of 2026.
Fractyl Health, Inc. reported randomized one-year data from the REMAIN-1 Midpoint Cohort evaluating its investigational Revita DMR System for weight maintenance after GLP-1 therapy discontinuation in adults with obesity. In the modified intention-to-treat population (N=45), a single Revita procedure reduced least-squares mean weight regain to 7.8% of body weight versus 13.0% with sham, a reduction of about 40% (n=29 Revita, 16 sham).
Among participants receiving complete duodenal ablation >14 cm, Revita patients had 4.8% weight regain versus 13.0% with sham, maintaining about 81% of GLP-1–induced weight loss at one year versus 48% with sham. In an optimized subgroup (complete ablation and ≥17.5% GLP-1 run-in loss), Revita maintained about 84% of weight loss versus 46% with sham (least-squares mean regain 4.1% vs 13.5%). The company notes these descriptive Midpoint results are not powered for formal inference but inform the pivotal design.
The weight-maintenance responder rate (≥5% total body weight loss vs pre-tirzepatide at one year), against an FDA performance goal >50%, was 73% in the Midpoint mITT population and 91% in the complete ablation group. No device- or procedure-related serious adverse events occurred; overall TEAE rates were 24% for Revita and 25% for sham, with one new diagnosis of type 2 diabetes in the sham arm and none with Revita. The REMAIN-1 Pivotal Cohort (≈315 patients) is fully randomized, with six-month topline data anticipated in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026. Fractyl reports $63M of cash on hand at the end of Q1 2026, with runway into early 2027.
Fractyl Health, Inc. held its 2026 Annual Meeting of Stockholders, where shareholders elected three Class II directors and ratified the company’s independent auditor. Ian Sheffield, Marc Elia, and Clive Meanwell were elected to three-year terms ending at the 2029 annual meeting.
Of 158,648,963 common shares outstanding as of April 17, 2026, 112,236,206 were represented at the meeting, reflecting approximately 70.7% of the voting power. Shareholders also approved the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Fractyl Health reported encouraging one-year results from its open-label REVEAL-1 Cohort evaluating the Revita procedure in people with obesity who stopped GLP-1 drugs after losing at least 15% of body weight. Participants had lost about 24% total body weight on GLP-1 therapy before enrollment.
After a single Revita procedure, patients retained roughly 78% of that GLP-1-induced weight loss at one year, with a mean total body weight change of 5.3% and 33% of participants continuing to lose weight. All patients maintained at least 5% of their prior weight loss.
Glycemic control was stable, with an HbA1c change of 0.08%, and there were no procedure-related serious adverse events. Mild treatment-emergent events occurred in 36% of participants, were transient, and appeared within the first month. Fractyl expects randomized REMAIN-1 data readouts in Q3 and early Q4 2026.
Fractyl Health, Inc. reported first quarter 2026 results and reiterated key clinical and cash runway milestones. For the quarter ended March 31, 2026, the company posted net income of $9.2 million, compared with a net loss of $23.7 million a year earlier, mainly due to a $30.1 million non-cash gain from changes in the fair value of warrant liabilities.
Operating expenses fell to $20.8 million from $24.8 million, and Adjusted EBITDA was a loss of $18.0 million versus a loss of $23.1 million in 2025. Cash and cash equivalents were $63.2 million as of March 31, 2026, which the company believes will fund operations into early 2027.
Fractyl highlighted progress for its Revita procedural therapy and Rejuva gene therapy platform, including completion of randomization in the REMAIN-1 pivotal cohort, planned Revita data readouts through Q4 2026, and Clinical Trial Authorization in the Netherlands for first-in-human testing of RJVA-001 in type 2 diabetes in the second half of 2026.
Fractyl Health, Inc. announced that it received Clinical Trial Application authorization in the Netherlands to start a Phase 1/2 first-in-human study of RJVA-001, its lead Rejuva Smart GLP-1 gene therapy candidate for type 2 diabetes. This authorization makes Fractyl a dual clinical-stage company, with Revita in pivotal development for post-GLP-1 weight maintenance and Rejuva entering first-in-human testing.
The company expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026, subject to site activation. Management states that Rejuva’s clinical development is funded within the existing cash runway into early 2027, beyond the anticipated REMAIN-1 pivotal data readout, with no change to capital plans.
Fractyl Health reported wider losses for Q4 and full-year 2025 while advancing its obesity and type 2 diabetes programs Revita and Rejuva. For the quarter ended December 31, 2025, research and development expenses were $16.5 million versus $20.3 million a year earlier, reflecting a strategic reprioritization.
Selling, general and administrative expenses rose to $6.8 million from $4.9 million, mainly from underwriters’ commissions on an August 2025 financing. Quarterly net loss increased to $43.7 million from $25.0 million, driven largely by a $20.2 million non-cash change in warrant liability fair value. Adjusted EBITDA was negative $21.2 million versus negative $22.1 million.
Fractyl ended December 31, 2025 with $81.5 million in cash and cash equivalents and later received $4.1 million from warrant exercises, and believes this will fund operations into early 2027. The company completed randomization in the REMAIN-1 Pivotal Cohort, reported dose-dependent six‑month weight maintenance data from the Midpoint Cohort, and plans pivotal six‑month topline results in early Q4 2026 followed by a potential De Novo marketing application in late Q4 2026 after favorable FDA feedback on a Class II device pathway.
Fractyl Health, Inc. has received a notice from Nasdaq that its common stock no longer meets the Nasdaq Global Market requirement for a minimum bid price of $1.00 per share, after trading below that level for 30 consecutive business days.
The company has 180 calendar days, until September 9, 2026, to regain compliance by having its stock close at or above $1.00 for at least 10 consecutive business days. If it fails to do so, it may seek to transfer to the Nasdaq Capital Market, potentially using measures such as a reverse stock split, or face possible delisting, with a right to appeal.
Fractyl Health, Inc. reported completion of participant randomization in REMAIN-1’s pivotal cohort, a randomized, double-blind, sham-controlled study of its Revita® endoscopic procedure for maintaining weight after GLP-1 therapy discontinuation. This marks a key step toward generating definitive clinical evidence in adults with obesity who previously lost at least 15% of body weight on tirzepatide.
The company expects topline 6‑month pivotal data in early Q4 2026 and is targeting a potential U.S. FDA marketing application submission in late Q4 2026, informed by anticipated Q2 2026 FDA feedback on possible De Novo pathway use. Fractyl also reiterated its cash runway guidance into early 2027, positioning it to fund operations through planned 2026 clinical and regulatory milestones for Revita.
Fractyl Health reported 6‑month interim results from its REMAIN‑1 Midpoint Cohort, a blinded, sham-controlled study of the Revita DMR System for weight maintenance after GLP‑1 drug discontinuation. In the prespecified efficacy population of 40 patients, Revita patients had 4.5% weight regain versus 7.5% with sham at 6 months.
Among patients with above‑median GLP‑1 run‑in weight loss (n=20), Revita patients regained 4.2% of weight versus 13.3% with sham, with a least‑squares mean difference of ‑9.1% and one‑sided p=0.004. Revita patients also showed better lipid profiles and lower sweet‑food cravings versus sham.
Revita maintained a favorable safety profile through six months, with no device‑ or procedure‑related serious adverse events or discontinuations. Fractyl has asked the FDA to consider De Novo classification for Revita and expects feedback in Q2 2026, alongside multiple additional clinical readouts through the second half of 2026.
Fractyl Health, Inc. has called all outstanding Tranche A common stock purchase warrants after achieving the trading performance targets that allowed it to do so. The company will cancel these warrants for cash consideration of $0.00001 per warrant at 6:30 p.m. New York City time on December 30, 2025, unless holders choose to exercise instead.
Holders may elect to exercise their Tranche A Warrants at an exercise price of $1.05 per underlying share of common stock up to the cancellation deadline. As of the notice date, 17,063,073 Tranche A Warrants were outstanding, and the last reported sale price of the common stock on Nasdaq on December 15, 2025 was $2.24 per share. The underlying shares have been registered under an effective SEC registration statement.
Fractyl Health, Inc. (GUTS) announced results for the quarter ended September 30, 2025 and provided a corporate update. The company furnished a press release as Exhibit 99.1 to its Form 8‑K.
The information in Item 2.02, including Exhibit 99.1, is being furnished and is not deemed filed under Section 18 of the Exchange Act. Fractyl Health’s common stock trades on the Nasdaq Global Market under the symbol GUTS.
Fractyl Health, Inc. held a Special Meeting of Stockholders on October 3, 2025, where stockholders voted on key matters related to a recent financing. Of the 50,289,014 shares of common stock outstanding as of August 6, 2025, a total of 32,249,473 shares were represented in person or by proxy, representing approximately 64.12% of the voting power entitled to vote.
Stockholders approved the issuance of shares of common stock pursuant to the exercise of warrants sold in a financing transaction that closed on August 7, 2025, as required under Nasdaq Listing Rule 5635(d). This proposal received 31,735,506 votes for, 411,848 votes against, and 102,119 abstentions. Stockholders also approved the potential adjournment of the Special Meeting, if necessary, to solicit additional proxies for the first proposal, with 31,744,878 votes for, 405,334 votes against, and 99,261 abstentions.
Fractyl Health, Inc. entered into an underwriting agreement with BofA Securities, Inc. and Evercore Group L.L.C. to sell 60 million shares of its common stock at $1.00 per share in an underwritten offering pursuant to an effective Form S-3 shelf registration. The company estimates net proceeds of approximately $56.0 million after underwriting discounts, commissions and estimated offering expenses. The closing is expected on September 29, 2025, subject to customary closing conditions. The filing references related exhibits including the Underwriting Agreement, legal opinion and consent of counsel, a press release dated September 26, 2025, and embedded cover page XBRL tags.
Fractyl Health, Inc. filed an 8-K that includes a press release and conference call presentation dated September 26, 2025 and is signed by CEO Harith Rajagopalan, M.D., Ph.D. The filing contains forward-looking statements about its development programs, including a reference to GLP-1 drug discontinuation and the design, timing and results of clinical studies such as readouts from the REMAIN-1 Midpoint Cohort. The company identifies material risks explicitly: limited operating history, significant and expected ongoing net losses, the need for substantial additional financing, potential going-concern issues, restrictive covenants in its credit agreement, and uncertainty in regulatory and clinical outcomes. The filing focuses on program timing and risks rather than disclosing financial results or transaction details.
Fractyl Health, Inc. announced changes to its board of directors. Effective September 2, 2025, Christopher Thompson, M.D. was appointed a Class I director with a term running to the 2028 annual meeting, and Ian Sheffield was appointed a Class II director with a term to the 2026 annual meeting. Sheffield also joined the audit committee.
Both new directors will receive a $43,500 annual cash retainer for board service, and Sheffield will receive an additional $10,000 for audit committee service. Each will receive an option to purchase 45,000 common shares, vesting in three equal annual installments. Amy W. Schulman resigned as a Class I director and committee member, and the company states her resignation was not due to any dispute or disagreement with the company or the board.
Fractyl Health, Inc. announced that it reported its financial results for the quarter ended June 30, 2025 and provided a corporate update, and the company furnished a related press release as Exhibit 99.1 to this Current Report. The filing states the press release is being "furnished" and therefore is not deemed "filed" for Section 18 liability purposes and is not incorporated by reference into other filings unless expressly stated.
The Current Report itself does not include the underlying financial figures or detailed metrics; investors must refer to the furnished Exhibit 99.1 press release for the actual results and any numerical detail.
Fractyl Health (NASDAQ: GUTS) announced positive 3-month data from the REVEAL-1 cohort of its REMAIN-1 pivotal study, showing promising results for weight management after GLP-1 discontinuation:
- 12 out of 13 participants maintained or lost weight after stopping GLP-1 treatment and receiving a single Revita procedure
- 6 participants achieved additional weight loss
- Median weight remained stable through 3 months, contrasting with typical 5-6% rebound in studies like SURMOUNT-4
- Procedure demonstrated strong safety profile with no serious adverse effects
Additionally, the company revealed new preclinical data for its Rejuva® Smart GLP-1™ pancreatic gene therapy platform. A single dose prevented obesity and hyperglycemia in animals on high-fat diets. The company expects REMAIN-1 Midpoint Cohort data in Q3 2025 and RJVA-001 preliminary clinical data in 2026.