Positive One Year REMAIN-1 Midpoint Cohort Results Set Up Key Pivotal Data In 4Q26: Fractyl Health Inc | North America

研报英文原文证据摘录

Positive One Year REMAIN-1 Midpoint Cohort Results Set Up Key Pivotal Data In 4Q26: Fractyl Health Inc | North America

Update

July 15, 2026 03:48 PM GMT

Morgan Stanley & Co. LLCMFractyl Health Inc | North America Michael E Ulz

Equity Analyst

Positive One Year REMAIN-1 Mike.Ulz@morganstanley.comRohit Bhasin +1 212 761-4650

Research Associate

Rohit.Bhasin@morganstanley.com +1 212 761-0534

Midpoint Cohort Results Set Up Avraham Novick

Avi.Novick@morganstanley.com +1 212 761-2231

Key Pivotal Data In 4Q26

Fractyl Health Inc (GUTS.O, GUTS US)

Biotechnology | United States of America

Key Takeaways Stock Rating Equal-weight

Industry View Attractive

One-year randomized REMAIN-1 Midpoint Cohort results show Revita reduced Price target $2.00

weight regain by ~40% versus sham at one year (7.8% vs. 13.0% regained; n=45) Shr price, close (Jul 14, 2026) $0.80

Mkt cap, curr (mm) $127

in mITT. 52-Week Range $2.45-0.38

One-year responder rate was 73% overall and 91% with complete ablation,

exceeding the FDA performance threshold of >50%.

Safety was favorable, with no device- or procedure-related serious adverse events

and comparable overall adverse event rates versus sham.

KOL noted durable ≥5% weight loss maintenance as clinically meaningful and

~10% weight loss as an optimal efficacy threshold in real-world practice.

We view the one-year data as encouraging ahead of key pivotal topline data

expected in early 4Q26.

Greater benefit observed in patients receiving complete duodenal ablations.

Fractyl reported one-year randomized data from the REMAIN-1 Midpoint Cohort

(press release and presentation), supporting durability of Revita for post-GLP-1

weight maintenance ahead of pivotal data later this year. In the modified intention-