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0.00558766859344897 0.0210019267822734 -0.000192678227360287 -0.0439306358381504 -0.0269749518304432 -0.0154142581888247 -0.015606936416185 0.00134874759152201
Stock impact report

Fractyl Health Q4 Earnings Call Highlights [Yahoo! Finance]

Fractyl Health, Inc. (GUTS) 
Company Research Source: Yahoo! Finance
New analyses show treatment “dose” — specifically ablation length — drives efficacy, with clear benefit at =16 centimeters ; in patients with 17.5% run-in weight loss Revita cut 6-month post-GLP-1 weight regain by ~70% (2.9% vs 9.9%) and preserved ~88% of tirzepatide-associated loss versus ~60% for sham. The pivotal REMAIN-1 trial has 300 patients across 30 U.S. sites, is powered 90% with mean run-in loss 18.3% and mean ablation 16 cm, and the company expects top-line 6-month pivotal data in early Q4 2026 and one-year midpoint randomized data in Q3 2026. Fractyl received favorable FDA feedback on a de novo pathway and plans de novo submission in late Q4 2026 and a Category III CPT filing in June 2026; the company has about $81.5M cash (plus $4.1M in Jan 2026), providing a cash runway into early 2027 and no planned capital raise before pivotal readout. Interested in Fractyl Health, Inc.? Here are five stocks we like better. Fractyl Health (NASDAQ:GUTS) used its fourth-quarter Show less Read more
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