secwatch.observer — SEC 8-K summary
======================================

Issuer:     Beam Therapeutics Inc. (BEAM)
CIK:        0001745999
Form:       8-K
Filed at:   2022-08-30T23:59:59+00:00
Accession:  0000950170-22-017868
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1745999/000095017022017868/0000950170-22-017868-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1745999/000095017022017868/beam-20220825.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-017868

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer