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BMEA Biomea Fusion

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 an organization centered on two of its core drug candidate …

Assets on file: BMF-650, icovamenib

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Decision-gradeMaterialNotableMinor
Oct 20, 2026
03:23 PM
BMEABiomea Fusion

icovamenib · NCT07502508 registry update

countries: {'total_sites': 17, 'us_sites': 17} → {'total_sites': 20, 'us_sites': 20}

Trial registry changeClinicalTrials.gov
Sep 22, 2026
08:01 PM
BMEABiomea Fusion

Biomea Fusion updates BMF-650 Phase 1 GLP-1 topline to October 2026

Biomea Fusion updated the expected timing for topline results from its ongoing Phase 1 GLP-131 trial of BMF-650 in obese, otherwise healthy volunteers. The data readout is now anticipated in October 2026.

Topline resultsSEC 8-KOpen record
Nov 4, 2025
09:03 PM
BMEABiomea Fusion

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

The 52-week follow-up from COVALENT-111 shows icovamenib delivered durable HbA1c reductions of 1.5% in severe insulin-deficient patients and 1.3% in GLP-1 non-responders after only 8–12 weeks of dosing. The safety profile remained comparable to placebo with no treatment-related discontinuations, supporting advancement into two new Phase II trials (COVALENT-211 and COVALENT-212) planned for Q4 2025 / Q1 2026.

Topline resultsSEC 8-KOpen record

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BMEA FDA Calendar & Catalysts — Biomea Fusion | Biopharma · FDA Approvals | SimianX AI