Asset profile

icovamenib · Biomea Fusion (BMEA)

Indication: type 2 diabetes
Also known as: BMF-219

Company

Biomea Fusion Inc is a a clinical stage diabetes and obesity medicines company focused on the discovery and development of oral, small molecule drugs to treat and improve the lives of patients with diabetes, obesity, and other metabolic diseases. It operate as…

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On the calendar

Mar 2027

~ Mar 2027

BMEABiomea Fusion

icovamenib: Phase 2 trial NCT07502495 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Jun 2027

~ Jun 2027

BMEABiomea Fusion

icovamenib: Phase 2 trial NCT07502508 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 20, 2026

03:23 PM

BMEABiomea Fusion

icovamenib · NCT07502508 registry update

Trial registry changeClinicalTrials.gov

Nov 4, 2025

09:03 PM

BMEABiomea Fusion

Biomea Fusion reports 52-week Phase II data for icovamenib in T2D

Topline resultsSEC 8-K Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 20, 2026

Primary endpoint metFavourable

Biomea Fusion reports 52-week Phase II data for icovamenib in T2D

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

83 of 88 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

BMEABiomea FusionOwner

SEC 8-K Nov 4, 2025

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT07502508	Phase 2	Recruiting	Jun 1, 2027	60	20 of 20 sites in the United States
NCT05731544	Phase 1/2	Completed	Nov 18, 2024	443	36 of 39 sites in the United States
NCT06152042	Phase 2	Completed	May 20, 2025	37	9 of 11 sites in the United States
NCT07502495	Phase 2	Active, not recruiting	Mar 1, 2027	64	18 of 18 sites in the United States

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