secwatch.observer — SEC 8-K summary
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Issuer:     Compass Therapeutics, Inc. (CMPX)
CIK:        0001738021
Form:       8-K
Filed at:   2026-09-22T12:30:16+00:00
Accession:  0001171843-26-006162
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA tells Compass to run survival trial before BLA for tovecimig; company disagrees
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- FDA recommended a survival-benefit trial before BLA submission for tovecimig in biliary tract cancer (BTC).
- Compass disagrees, citing COMPANION-002: ORR 18.0% vs 5.3% (p=0.0228); median PFS 4.7 vs 2.6 months, HR 0.44 (p<0.0001).
- Overall survival missed statistical significance due to high crossover and prolonged survival in crossover patients.
- Company plans further FDA engagement, intends to proceed with BLA; full data to be presented at a medical conference this year.
- CEO Thomas Schuetz acknowledged the feedback and said priority is working with the FDA on the best path forward.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1738021/000117184326006162/0001171843-26-006162-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1738021/000117184326006162/f8k_092226.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-006162

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