Fractyl Health (NASDAQ:GUTS – Get Free Report) issued its quarterly earnings data on Tuesday. The company reported $0.06 earnings per share (EPS) for the quarter, topping the consensus estimate of ($0.17) by $0.23, FiscalAI reports.
Here are the key takeaways from Fractyl Health’s conference call:
- Fractyl said Revita’s clinical signal remains real, citing DDW presentation momentum, strong physician interest, and confirmation that the dose-response and patient-selection findings are being viewed favorably by experts.
- The company said the REMAIN-1 pivotal trial is on track, with more than 300 randomized participants, over 90% retention, low medication-resumption rates, and top-line 6-month data still expected in early Q4 2026.
- Management reiterated that the regulatory path looks constructive, pointing to favorable FDA feedback on De Novo classification and saying it expects to submit the Revita marketing application in late Q4 2026 with pivotal data in hand.
- Fractyl highlighted multiple commercialization tailwinds, including the new CMS/FDA RAPID pathway, upcoming CPT coding work, and expanding GLP-1 access that could increase the future population at risk for weight rebound.
- The company also advanced Rejuva, receiving authorization in the Netherlands to begin first-in-human RJVA-001 testing and expecting first patient dosing and preliminary data in the second half of 2026, while keeping this program funded within current cash runway.
- Fractyl ended Q1 with $63.2 million in cash and said it expects runway into early 2027, reaffirming it does not plan to raise capital before pivotal data is available.
Fractyl Health Trading Up 1.2%
NASDAQ:GUTS traded up $0.01 during midday trading on Thursday, hitting $0.96. 3,091,334 shares of the company traded hands, compared to its average volume of 4,442,604. The firm’s fifty day moving average is $0.54 and its 200-day moving average is $1.13. Fractyl Health has a 12-month low of $0.38 and a 12-month high of $3.03. The firm has a market capitalization of $152.30 million, a P/E ratio of -0.74 and a beta of 2.11. The company has a current ratio of 4.78, a quick ratio of 4.78 and a debt-to-equity ratio of 3.23.
Institutional Inflows and Outflows
Analysts Set New Price Targets
GUTS has been the topic of several recent research reports. Morgan Stanley cut Fractyl Health from an “overweight” rating to an “equal weight” rating and decreased their price objective for the stock from $8.00 to $2.00 in a report on Thursday, January 29th. Weiss Ratings reaffirmed a “sell (e+)” rating on shares of Fractyl Health in a report on Tuesday. HC Wainwright reaffirmed a “buy” rating and set a $8.00 price objective on shares of Fractyl Health in a report on Friday, April 24th. Finally, Canaccord Genuity Group reaffirmed a “buy” rating and set a $8.00 price objective on shares of Fractyl Health in a report on Thursday, March 26th. Three research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company. Based on data from MarketBeat, the company has an average rating of “Hold” and a consensus target price of $5.40.
Read Our Latest Research Report on Fractyl Health
Fractyl Health Company Profile
Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control.
The company’s lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine.
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