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Fractyl Health Submits Clinical Trial Application in Europe

Story Highlights
  • Fractyl Health submitted a Clinical Trial Application in Europe for RJVA-001, a gene therapy for T2D.
  • The study could transform diabetes treatment from daily management to a one-time therapy, impacting industry positioning.
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An announcement from Fractyl Health, Inc. ( (GUTS) ) is now available.

On May 19, 2025, Fractyl Health, Inc. announced the submission of the first module of its Clinical Trial Application in Europe for RJVA-001, a gene therapy candidate from its Rejuva platform. This marks a significant step in advancing their novel approach to treating type 2 diabetes and obesity by targeting pancreatic beta cells to enable physiologic hormone secretion. The upcoming Phase 1/2 study will assess the safety, tolerability, and preliminary efficacy of RJVA-001, potentially transforming diabetes treatment from daily management to a one-time therapy. If successful, this could significantly impact the company’s operations and industry positioning by offering a commercially viable path to durable disease remission.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Spark’s Take on GUTS Stock

According to Spark, TipRanks’ AI Analyst, GUTS is a Neutral.

Fractyl Health’s stock is weighed down by its precarious financial situation, characterized by high leverage and ongoing losses. Despite promising advancements in clinical trials and market interest, significant financial risks and valuation concerns persist. Technical indicators show some positive momentum, but caution is advised due to potential overbought conditions.

To see Spark’s full report on GUTS stock, click here.

More about Fractyl Health, Inc.

Fractyl Health, Inc. is a metabolic therapeutics company based in Burlington, MA, focused on pioneering treatments for obesity and type 2 diabetes (T2D). The company aims to transform the management of metabolic diseases by developing durable, disease-modifying therapies that target the root causes of these conditions, moving beyond chronic symptomatic management.

Average Trading Volume: 242,997

Technical Sentiment Signal: Buy

Current Market Cap: $82.77M

For a thorough assessment of GUTS stock, go to TipRanks’ Stock Analysis page.

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