secwatch.observer — SEC 8-K summary
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Issuer:     Compass Therapeutics, Inc. (CMPX)
CIK:        0001738021
Form:       8-K
Filed at:   2024-04-25T23:59:59+00:00
Accession:  0001171843-24-002220
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants Fast Track Designation for Compass's CTX-009 in biliary tract cancer
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- FDA Fast Track Designation for CTX-009 (bispecific DLL4/VEGF-A antibody) + paclitaxel in previously treated metastatic/locally advanced biliary tract cancer.
- Phase 2 data showed ORR 37.5% (9/24), median PFS 9.4 months, median OS 12.5 months.
- Enrollment in Phase 2/3 COMPANION-002 study expected to complete mid-2024; top-line data by year-end 2024.
- Co-founder Thomas Schuetz highlighted large unmet need with current single-digit response rates.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1738021/000117184324002220/0001171843-24-002220-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1738021/000117184324002220/f8k_042424.htm
  HTML page:      https://secwatch.observer/filing/0001171843-24-002220

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