secwatch.observer — SEC 8-K summary
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Issuer:     Allogene Therapeutics, Inc. (ALLO)
CIK:        0001737287
Form:       8-K
Filed at:   2023-12-19T23:59:59+00:00
Accession:  0001737287-23-000096
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Allogene gets FDA Fast Track for ALLO-647; safety data from 87 patients at ASH
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- FDA granted Fast Track Designation for ALLO-647 in adult patients with r/r LBCL.
- Safety review of 87 Phase 1 patients: no unexpected safety concerns, no GvHD or Grade ≥3 ICANS.
- 33 CAR T-naïve LBCL patients had 42% CR rate, median DOR 23.1 months.
- EXPAND trial (N=70 r/r LBCL) enrolling in US/EU to support licensure of ALLO-647.
- Grade ≥3 cytopenias decreased over time; rates consistent with autologous CAR T therapy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737287/000173728723000096/0001737287-23-000096-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737287/000173728723000096/allo-20231209.htm
  HTML page:      https://secwatch.observer/filing/0001737287-23-000096

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