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Phase 3Update

IMCIVREE™ (Setmelanotide)

Genetically [POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1] caused MC4R pathway diseases

RYTMRhythm Pharmaceuticals
Expected catalystTBA

Catalyst overview

Event details

Drug or asset
IMCIVREE™ (Setmelanotide)
Development stage
Phase 3
Event type
Update
Indication
Genetically [POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1] caused MC4R pathway diseases

Research summary

What is being tracked?

This catalyst tracks a Phase 3 update for IMCIVREE™ (Setmelanotide) in Genetically [POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1] caused MC4R pathway diseases. The expected timing is based on the latest available company guidance and may change.

Development notes

DAYBREAK & EMANATE trials. 11/4/24- Reported Ph2 data at ObesityWeek®'24. 2/26/25- Enrollment completed. 8/5/25- Topline data in Q1 2026. 11/04/25:- PR No update 02/26/26:- EMANATE Ph3 topline data now guided for March 2026. 03/16/26:- EMANATE Ph3 missed primary endpoints; post hoc showed BMI reduction in POMC/PCSK1 and SRC1; no new safety signals. 05/05/26:- EMANATE Phase 3 miss restated; no new development milestones disclosed. 08/04/26:- POMC/LEPR long-term weight data presentations noted; no new EMANATE milestone disclosed.

Verification

Primary source

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

Open source

More from RYTM

Related pipeline programs

Approved

IMCIVREE™ (Setmelanotide)

Acquired Hypothalamic Obesity (HO)

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Phase 1/2

RM-718

Acquired hypothalamic obesity (HO)

View company pipeline

Company

Rhythm Pharmaceuticals

RYTM · NasdaqGM
Industry
Biotechnology
Pipeline assets
10
View RYTM research

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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
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