GUTS

Fractyl Health's stock has experienced significant volatility over the past six months. In January 2026, the stock plunged by approximately 68.03% after the company released six-month data from the REMAIN-1 Midpoint Cohort, which showed a 4.5% weight regain in Revita-treated patients versus 7.5% in the sham arm, falling short of expectations, and the CEO acknowledged operational issues at a study site. This led to a downgrade by Morgan Stanley and the stock reaching an all-time low of $0.3772 on February 4, 2026. In May 2026, the company reported its first-quarter 2026 financial results, showing a net income of $9.2 million, a significant improvement compared to a net loss of $23.7 million in the same period of 2025. In August 2026, shares jumped 20.9% after its Q4 2025 results and new weight-maintenance data from the REMAIN-1 Midpoint Cohort, with the company also announcing anticipated clinical and regulatory milestones for Revita, including topline 6-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026. By September 2026, reports indicated that Fractyl Health was facing Nasdaq delisting and planning a reverse split, with the stock price at $0.60 per share, representing a 39.50% decline from September 22, 2025. Additionally, multiple class-action lawsuits have been filed against the company, alleging misleading statements regarding Revita's effectiveness and compromised trial data due to operational issues, with an October 20, 2026, deadline for investors to apply to serve as lead plaintiff.