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BURLINGTON, Mass. - Fractyl Health, Inc. (NASDAQ:GUTS), a $91.1 million market cap biotech company currently trading at $1.87, reported Tuesday that a single Revita procedure led to sustained weight loss and improved glucose control over two years in patients with obesity and type 2 diabetes, according to data from its Germany Real-World Registry study. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value calculations, despite being in its pre-commercial phase.
The study followed nine participants who achieved a median weight loss of 9.6% after the procedure, with results maintained throughout the two-year follow-up period. Seven of eight evaluable participants experienced at least 5% weight reduction, with five achieving reductions of 10% or more. While the clinical results are promising, InvestingPro data shows the company is currently burning through cash, with a healthy current ratio of 2.5x providing some operational runway.
Participants also saw their median HbA1c levels decrease by 1.6%, from 9.6% at baseline to 7.0% at the two-year mark, while reducing or stabilizing their use of glucose-lowering medications.
The registry study participants had a median age of 62 years, median weight of 104 kg (229 lbs), and median HbA1c of 9.6% at baseline, despite being on up to three glucose-lowering agents. No device or procedure-related serious adverse events have been reported to date.
"These results reinforce what we saw in earlier clinical studies in people living with obesity and type 2 diabetes," said Harith Rajagopalan, CEO of Fractyl Health, in the press release.
The Revita procedure is designed to remodel the duodenal lining to address metabolic disease. It currently holds FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 based drugs.
Fractyl expects midpoint cohort data from its pivotal REMAIN-1 study in the third quarter of 2025, with primary endpoint data anticipated in the second half of 2026. The REMAIN-1 study is evaluating Revita’s potential for maintaining weight loss after GLP-1 discontinuation.
In the United States, Revita remains for investigational use only. The Germany Real-World Registry study is no longer enrolling new patients but will continue follow-up with current participants. With analyst price targets ranging from $6 to $12 and the next earnings report due on August 13, 2025, investors can access comprehensive analysis and 10 additional key insights through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, Fractyl Health has reported positive three-month data from its REVEAL-1 study, showing that most participants either maintained or lost weight after discontinuing GLP-1 therapy and undergoing the Revita procedure. The study highlighted that 12 out of 13 participants maintained or lost weight, with six individuals losing additional weight, and a median weight change of approximately one pound. Additionally, Fractyl Health has been granted two new U.S. patents for its duodenal resurfacing technology, which is a key component of its Revita device used for treating metabolic disorders.
In terms of analyst activity, Canaccord Genuity has reiterated its Buy rating on Fractyl Health, setting a price target of $12.00, following the presentation of updated data from its Phase 3 trial of Revita. Meanwhile, Evercore ISI has maintained its outperform rating on the company after the positive results from the REVEAL-1 study. Furthermore, Fractyl Health has advanced its gene therapy efforts by submitting the first module of its Clinical Trial Application in Europe for RJVA-001, a gene therapy candidate targeting type 2 diabetes and obesity. The company plans to initiate first-in-human dosing and report preliminary data in 2026, pending regulatory approval. These developments underscore Fractyl Health’s ongoing efforts in metabolic therapeutics.
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