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Phase 2Data readout

Revita

Obesity, Type 2 diabetes

GUTSFractyl Health
Expected catalystNovember 15, 2026Company guidance: Nov 15, 2026

Catalyst overview

Event details

Drug or asset
Revita
Development stage
Phase 2
Event type
Data readout
Indication
Obesity, Type 2 diabetes
Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a Phase 2 data readout for Revita in Obesity, Type 2 diabetes. The expected timing is based on the latest available company guidance and may change.

Development notes

REMAIN-1, REVEAL-1 trials. 4/1/25- REVEAL-1 prelim data reported. 6/23/25- 3mth REVEAL-1 cohort data reported. 9/26/25- REMAIN-1 Midpoint cohort 3mth data announced; met key efficacy endpoint. 6mth primary endpoint data in Q1 2026. REMAIN-1 Pivotal cohort 6mth endpoint data in H2 2026. 11/12/25:- Revita randomized REMAIN-1 data positive; Germany registry 2-year outcomes favorable; multiple cohort data catalysts Q4 2025–H2 2026. 01/29/26:- 6m Midpoint data positive. 1y REVEAL-1 Q2 2026, 1y Midpoint Q3 2026, pivotal 6m and FDA filing H2 2026. 02/26/26:- REMAIN-1 Pivotal randomization completed; De Novo feedback Q2 2026; pivotal 6m data early Q4 2026; filing late Q4 2026. 03/24/26:- New Midpoint post-hoc data; pivotal randomization complete; Q2–Q4 2026 REVEAL-1, Midpoint, pivotal 6m and De Novo milestones. 05/12/26:- Revita Q2–Q4 2026 REVEAL-1, Midpoint, pivotal 6m data and late Q4 2026 De Novo submission timelines reaffirmed. 06/04/26:- REVEAL-1 1y weight maintenance positive. Next REMAIN-1 Midpoint 1y data Q3 2026; Pivotal 6m topline Early Q4 2026. 07/15/26:- REMAIN-1 Midpoint Cohort 1y results positive. Pivotal 6m topline Early Q4 2026; De Novo filing Late Q4 2026. 08/10/26:- One-year data were detailed. Pivotal 6m expected Early Q4 2026, De Novo Late Q4, 1y Q1 2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

Company

Fractyl Health

GUTS · NasdaqGM
Industry
Biotechnology
Pipeline assets
3
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy