---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-157310"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2024-06-07T23:59:59+00:00"
generated_at: "2026-06-01T05:41:17.706984+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA places full clinical hold on Biomea Fusion's BMF-219 diabetes trials due to liver enzyme elevations

## Summary
- Full clinical hold on Phase I/II COVALENT-111 and COVALENT-112 for BMF-219 in type 2 and type 1 diabetes.
- FDA cited potential drug-induced hepatotoxicity; higher doses up to 400 mg may have contributed to liver enzyme elevations.
- Most adverse events mild to moderate; no serious adverse reactions reported to date with BMF-219.
- Company continues data collection during hold; collaborating with FDA to resolve clinical hold quickly.

## SEC filing metadata
- accession: 0001193125-24-157310
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2024-06-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312524157310/0001193125-24-157310-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312524157310/d94044d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-157310
- JSON: https://secwatch.observer/filing/0001193125-24-157310.json
- Plain text: https://secwatch.observer/filing/0001193125-24-157310.txt

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