Fractyl Health gains after FDA allows study of weight management device
01/04/2024 12:12
** Shares of Fractyl Health GUTS.O rise 5.3% to $7.79 in
premarket trading
** Co says U.S. health regulator has approved request to
study the efficacy of its investigational device, Revita, for
weight loss maintenance
** Revita is designed to surgically remodel the duodenal
lining of the small intestine, which receives food from the
stomach and begins absorption of nutrients
** Co says study, Remain-1, will test Revita versus a sham
treatment in patients who have lost at least 15% total body
weight on tirzepatide
** GUTS plans to begin the study in H2 2024
** Study results to support regulatory filing for use of
Revita for weight maintenance after patients discontinue use of
GLP-1 drugs such as tirzepatide, company says
** Currently, Eli Lilly's LLY.N tirzepatide is approved
under the brand names Mounjaro for type 2 diabetes and Zepbound
for obesity in the United States
** As of last close, GUTS down 46.2% since market debut on
Feb. 2
(Reporting by Bhanvi Satija in Bengaluru)
((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))