---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-264447"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2022-10-18T23:59:59+00:00"
generated_at: "2026-06-23T03:04:57.007206+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Biomea Fusion announces FDA IND clearance for BMF-219 in KRAS solid tumors; Phase I/Ib trial to begin

## Summary
- FDA cleared IND for BMF-219 to initiate Phase I/Ib trial (COVALENT-102) in KRAS-mutant NSCLC, CRC, and PDAC.
- BMF-219 is the first menin inhibitor to enter clinical trials for solid tumors.
- Preclinical data showed pan-KRAS activity across G12C, G12D, G12V, and G13D mutations.
- Company already has COVALENT-101 Phase I trial in blood cancers underway.
- KRAS mutations present in 25-35% of NSCLC, 35-45% of CRC, and ~90% of PDAC patients.

## SEC filing metadata
- accession: 0001193125-22-264447
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2022-10-18T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312522264447/0001193125-22-264447-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312522264447/d403732d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-264447
- JSON: https://secwatch.observer/filing/0001193125-22-264447.json
- Plain text: https://secwatch.observer/filing/0001193125-22-264447.txt

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