24/7 Market News Snapshot 19 May, 2025 – Fractyl Health, Inc. Common Stock (NASDAQ:GUTS)

May 19, 2025

DENVER, Colo., 19 May, 2025 (www.247marketnews.com) – (NASDAQ:GUTS) are discussed in this article.
Fractyl Health, Inc. is currently experiencing significant momentum in the market, with its shares opening at $1.62 and rising to approximately $2.020, marking an impressive increase of about 19.53%. This surge follows a previous closing price of $1.690, indicative of a strong bullish sentiment among investors. With a trading volume of 509.64K, the heightened interest suggests a potential breakout as traders closely monitor for continued upward movement or possible resistance levels to better understand future price trajectories. The accompanying robust volume implies a strong trend continuation could be realized if the current momentum persists in the forthcoming sessions.

In tandem with its market performance, Fractyl Health is poised to revolutionize the treatment paradigm for obesity and type 2 diabetes (T2D) by announcing a pioneering first-in-human study for RJVA-001, a pancreas-targeted gene therapy. This innovative therapy is designed to enhance glucagon-like peptide-1 (GLP-1) signaling, addressing a critical need for patients struggling with T2D. The company has taken a significant step forward by submitting the initial module of its Clinical Trial Application (CTA) in Europe, which could lead to new treatment options beyond conventional GLP-1-based therapies.

RJVA-001 operates by facilitating localized GLP-1 expression in pancreatic beta cells, thereby ensuring effective hormone secretion without the excessive circulating hormone levels typically associated with standard treatments. Administered through a minimally invasive endoscopic ultrasound-guided infusion directly to the pancreas, this therapy holds promise for achieving physiological control over GLP-1 release.

Pending regulatory approval, Fractyl is set to initiate patient dosing and expects to disclose preliminary results from its study in 2026. Targeting adult participants with uncontrolled T2D, this Phase 1/2 study aims to evaluate both safety and initial efficacy, representing a significant shift from cyclical management of metabolic diseases to long-term disease modification.

“Completing our first CTA submission for RJVA-001 is a vital milestone in our commitment to transforming metabolic disease treatment,” stated Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health. “We believe RJVA-001 could redefine the narrative around diabetes treatment and potentially lead to remission.”

Fractyl Health is at the forefront of developing next-generation gene therapies through its Rejuva platform, targeting the root causes of obesity and T2D, while remaining dedicated to improving health outcomes for patients worldwide.

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