---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-22-017868"
form_type: "8-K"
ticker: "BEAM"
cik: "0001745999"
company_name: "Beam Therapeutics Inc."
filed_at: "2022-08-30T23:59:59+00:00"
generated_at: "2026-06-23T19:34:15.067687+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Beam announces FDA formal clinical hold letter for BEAM-201 IND; plans Q4 2022 response

## Summary
- FDA placed BEAM-201 IND on clinical hold for relapsed/refractory T-ALL/T-LBL.
- Letter dated Aug 25 requests additional control data and off-target editing analyses.
- Requests also include additional cytokine assay data and updated investigator brochure.
- Beam intends to complete studies and submit Complete Response in Q4 2022.

## SEC filing metadata
- accession: 0000950170-22-017868
- form_type: 8-K
- ticker: BEAM
- cik: 0001745999
- company_name: Beam Therapeutics Inc.
- filed_at: 2022-08-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1745999/000095017022017868/0000950170-22-017868-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1745999/000095017022017868/beam-20220825.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-22-017868
- JSON: https://secwatch.observer/filing/0000950170-22-017868.json
- Plain text: https://secwatch.observer/filing/0000950170-22-017868.txt

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