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BURLINGTON, Mass. - Fractyl Health, Inc. (NASDAQ:GUTS), a clinical-stage medical technology company with a market capitalization of $104.8 million, reported Monday that most participants maintained or lost weight three months after discontinuing GLP-1 therapy and receiving its Revita procedure, according to data from the REVEAL-1 cohort of its REMAIN-1 pivotal study. The company’s stock has shown strong momentum recently, with a notable upward trend over the past three months, according to InvestingPro data.
The data showed 12 of 13 participants either maintained or lost weight after stopping GLP-1 medications and undergoing a single Revita procedure, with six individuals losing additional weight. The median weight change was 0.46% (approximately one pound), compared to the typical 5-6% weight regain (10-15 pounds) observed when patients discontinue GLP-1 therapies. While these clinical results are promising, InvestingPro analysis reveals the company is currently operating at a significant EBITDA loss of $95.8 million, highlighting the importance of successful commercialization.
The REVEAL-1 cohort includes individuals with obesity who had lost at least 15% of their total body weight on GLP-1 therapy before discontinuation. Participants had a median total body weight loss of 20.9% while on GLP-1 medications, which they had used for periods ranging from approximately five months to three years.
"These early Revita data suggest the potential to prevent the weight regain we see in practice," said Shelby Sullivan, Professor of Medicine at the Geisel School of Medicine at Dartmouth University, in the company’s press release.
The procedure demonstrated a favorable safety profile with no serious adverse effects reported. Treatment-related adverse events were infrequent, mild, and transient, occurring in three patients and lasting 2-5 days.
Revita is designed to remodel the duodenal lining to address metabolic issues and has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 drugs.
Fractyl expects to report data from the randomized Midpoint Cohort in the third quarter of 2025, with the 6-month primary endpoint data from the Pivotal Cohort anticipated in the second half of 2026. Wall Street analysts maintain a bullish outlook on the company, with price targets ranging from $6 to $12 per share. For deeper insights into Fractyl Health’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, visit InvestingPro.
In other recent news, Fractyl Health has reported its Q1 2025 earnings, highlighting a significant increase in research and development expenses, which surged to $19.4 million from $14.4 million in the previous year. This increase contributed to a widened net loss of $23.7 million, compared to a $3.3 million loss in Q1 2024. The company maintains a strong cash position with $42.1 million on hand, ensuring operational stability into late 2025. Fractyl Health has also made strides in its intellectual property portfolio with the issuance of two new U.S. patents for its duodenal resurfacing technology, central to its Revita device. Additionally, the company has advanced its gene therapy candidate, RJVA-001, for type 2 diabetes and obesity by submitting the first module of its Clinical Trial Application in Europe. The company plans to initiate first-in-human dosing and report preliminary data in 2026, pending regulatory approval. Fractyl Health is also expecting pivotal data releases and regulatory submissions in the latter half of 2025, indicating a period rich with potential catalysts.
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