---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-132621"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2023-05-02T23:59:59+00:00"
generated_at: "2026-06-16T03:48:48.788817+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Biomea Fusion receives FDA clearance for IND of BMF-500 in relapsed/refractory acute leukemia

## Summary
- FDA cleared IND for BMF-500, a novel covalent FLT3 inhibitor, to begin Phase I trial COVALENT-103 in adult patients with relapsed or refractory acute leukemia.
- BMF-500 is the second investigational compound from Biomea's FUSION System to enter the clinic.
- Preclinical data: BMF-500 showed ~20-fold greater potency than gilteritinib and >50-fold greater than reversible menin/MLL inhibitors in AML cell lines.
- Combination of BMF-500 and BMF-219 showed greater than additive cell killing in acute leukemia cell lines and patient samples.
- BMF-500 designed for high target selectivity with minimal off-target liabilities; potential for combinations with standard of care or BMF-219.

## SEC filing metadata
- accession: 0001193125-23-132621
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2023-05-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312523132621/0001193125-23-132621-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312523132621/d851586d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-132621
- JSON: https://secwatch.observer/filing/0001193125-23-132621.json
- Plain text: https://secwatch.observer/filing/0001193125-23-132621.txt

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