---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-283008"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2024-12-20T23:59:59+00:00"
generated_at: "2026-05-29T00:29:22.056276+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Biomea Fusion icovamenib Phase II meets primary endpoint; 1.47% HbA1c reduction in insulin-deficient T2D patients

## Summary
- Best response in beta-cell deficient patients on antidiabetic agents: placebo-adjusted HbA1c reduction 1.47% at Week 26 (p=0.022) after 12 weeks dosing.
- Arm B (100mg QD for 12 weeks) showed mean HbA1c reduction of 0.5% (p=0.012) in per protocol patients on one or more baseline therapy.
- In insulin-deficient subtypes (SIDD/MARD), Arm B demonstrated mean HbA1c reduction of 1.05% (p=0.004).
- Icovamenib well-tolerated: no AE-related discontinuations, no hypoglycemic events, no related serious adverse events.
- Company plans to discuss data with FDA; 52-week readout anticipated in H2 2025.

## SEC filing metadata
- accession: 0001193125-24-283008
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2024-12-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312524283008/0001193125-24-283008-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312524283008/d827448d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-283008
- JSON: https://secwatch.observer/filing/0001193125-24-283008.json
- Plain text: https://secwatch.observer/filing/0001193125-24-283008.txt

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