US Market News
4月前
Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTSJanuary 30, 2026 11:46 AM
Business Wire
The DJS Law Group announces that it is investigating claims on behalf of investors of Fractyl Health, Inc. (“Fractyl Health” or “the Company”) (NASDAQ: GUTS) for violations of the securities laws.
INVESTIGATION DETAILS: The investigation focuses on whether the Company issued misleading statements and/or failed to disclose information pertinent to investors. Benzinga reported on January 29. 2026, that Fractyl Health “requested FDA feedback on potentially reclassifying Revita under the De Novo pathway, rather than a Premarket Approval (PMA).” Based on this news, shares of Fractyl Health fell by 67.48% in intraday trading on the same day.
If you are a shareholder who suffered a loss, contact us to participate.
WHY DJS LAW GROUP? DJS Law Group’s primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260130967015/en/
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.com
Original: Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTS
US Market News
4月前
Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTSJanuary 29, 2026 4:16 PM
Business Wire
The DJS Law Group announces that it is investigating claims on behalf of investors of Fractyl Health, Inc. (“Fractyl Health” or “the Company”) (NASDAQ: GUTS) for violations of the securities laws.
INVESTIGATION DETAILS: The investigation focuses on whether the Company issued misleading statements and/or failed to disclose information pertinent to investors. Benzinga reported on January 29. 2026, that Fractyl Health “requested FDA feedback on potentially reclassifying Revita under the De Novo pathway, rather than a Premarket Approval (PMA).” Based on this news, shares of Fractyl Health fell by 67.48% in intraday trading on the same day.
If you are a shareholder who suffered a loss, contact us to participate.
WHY DJS LAW GROUP? DJS Law Group’s primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260129695168/en/
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.co
Original: Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTS
iHub News
4月前
Fractyl Health shares slide after interim GLP-1 weight-maintenance dataJanuary 29, 2026 10:05 AM
IH Market News
Fractyl Health (NASDAQ:GUTS) shares plunged around 35% after the company released six-month randomized midpoint data from its REMAIN-1 trial studying Revita as a weight-maintenance therapy following discontinuation of GLP-1 drugs.The company said patients treated with Revita regained 4.5% of body weight at six months, compared with 7.5% in the sham group, suggesting some moderation of the typical rebound seen after stopping GLP-1 therapy. In an exploratory subgroup of patients who achieved above-median weight loss during the GLP-1 run-in phase, Revita recipients recorded 4.2% weight regain versus 13.3% in the sham arm.While Fractyl described the findings as encouraging, the market reaction was sharply negative. The company emphasized that the study was not designed or powered to formally assess efficacy, which may have tempered investor confidence.Beyond weight outcomes, Fractyl reported that Revita-treated patients showed improvements in several cardiometabolic markers at six months, including higher HDL cholesterol and a lower triglyceride-to-HDL ratio. Patient-reported outcomes also indicated a meaningful reduction in sweet-food cravings compared with sham treatment.On the regulatory front, Fractyl said it has asked the U.S. Food and Drug Administration for guidance on pursuing a De Novo classification for Revita rather than a Premarket Approval route, with feedback expected in the second quarter of 2026. The company plans to release topline six-month pivotal data and potentially submit a regulatory filing in the second half of 2026.Fractyl added that it continues to progress toward multiple clinical and regulatory milestones within its REMAIN-1 weight-maintenance program, with full randomization of the pivotal cohort expected to be completed in February 2026.
Original: Fractyl Health shares slide after interim GLP-1 weight-maintenance data
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