Top Biotechnology Stock: H.C. Wainwright Highlights Fractyl Health

Fractyl Health (GUTS) shares rose 2.8% pre-market ahead of a Virtual Commercial Strategy Day. The company will discuss its Revita therapy's commercial strategy and market opportunity, following positive REMAIN-1 clinical data. Analysts have differing ratings, with Bank of America issuing a 'Buy' and Morgan Stanley a 'Hold'. The company targets FDA application in late 2026.

Fractyl Health (GUTS) stock rose 2.8% in pre-market trading ahead of its Virtual Commercial Strategy Day, where management will discuss the commercial strategy for Revita, its procedural therapy. Recent clinical data showed patients maintained 84% of GLP-1-induced weight loss. Analysts from Bank of America and Morgan Stanley have differing ratings. The move is driven by company-specific catalysts, not broader market trends.

FRACTYL HEALTH, INC. (GUTS) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Fractyl Health Reports Second Quarter 2026 Financial Results and Business Updates One-year REMAIN-1 Midpoint Cohort data show Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablation

Fractyl Health reported one-year results for its Revita procedure in a 45-participant modified intention-to-treat group. Revita cut weight regain versus sham, with least-squares mean regain of 7.8% vs 13.0%. In higher-intensity duodenal ablation subgroups, it preserved about 81% to 84% of GLP-1 weight loss. Safety was similar between groups. Shares rose 19.54% to $0.85.

Fractyl Health (GUTS) reported one-year randomized REMAIN-1 midpoint cohort results for its Revita duodenal mucosal resurfacing system in patients who stopped GLP-1 therapy. In 45 participants, Revita cut weight regain versus sham (7.8% vs 13.0% of body weight). Responder rates were 73% vs sham, rising to 91% with complete ablation. Stock rose to $0.80.

Fractyl Health (Nasdaq: GUTS) reported one-year, randomized sham-controlled REMAIN-1 midpoint cohort results for its Revita DMR system after GLP-1 discontinuation. In mITT (N=45), weight regain was 7.8% vs 13.0% with sham. Complete duodenal ablation (>14 cm) retained ~81% vs 48% with sham. No device-related serious AEs. Next: six-month pivotal topline in early Q4 2026 and possible FDA De Novo late Q4 2026.