---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-231903"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2025-10-06T23:59:59+00:00"
generated_at: "2026-05-17T04:37:27.160039+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Biomea Fusion reports 52-week Phase II COVALENT-111 data: HbA1c reductions up to 1.5% in severe insulin-deficient T2D

## Summary
- In severe insulin-deficient T2D patients (n=10), icovamenib achieved durable HbA1c reduction of 1.2% (p=0.01) through Week 52 after 12 weeks dosing.
- Best result in Arm B (n=6): mean HbA1c reduction of 1.5% (p=0.01); no treatment-related serious adverse events.
- In patients on GLP-1 therapy not at glycemic targets (n=11), icovamenib added 1.3% HbA1c reduction (p=0.05) sustained to Week 52.
- Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D expected to start Q4 2025; Phase II with GLP-1 (COVALENT-212) also Q4.
- Food Effect Study (COVALENT-121) ongoing, expected completion by December 2025; oral GLP-1 RA (BMF-650) Phase I data anticipated H1 2026.

## SEC filing metadata
- accession: 0001193125-25-231903
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2025-10-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312525231903/0001193125-25-231903-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312525231903/d79150d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-231903
- JSON: https://secwatch.observer/filing/0001193125-25-231903.json
- Plain text: https://secwatch.observer/filing/0001193125-25-231903.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.