secwatch.observer — SEC 8-K summary
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Issuer:     COMPASS Pathways plc (CMPS)
CIK:        0001816590
Form:       8-K
Filed at:   2026-02-17T23:59:59+00:00
Accession:  0001816590-26-000007
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Compass Pathways: Phase 3 COMP006 meets primary endpoint; COMP360 25mg shows -3.8 point MADRS reduction (p<0.001)
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- COMP006: Two 25mg doses vs 1mg showed -3.8 point MADRS reduction (p<0.001) at Week 6, meeting primary endpoint.
- 39% of COMP006 25mg arm achieved clinically meaningful reduction (≥25% MADRS) at Week 6.
- COMP005 single dose previously showed -3.6 point difference (p<0.001); durable effect through Week 26 after 1-2 doses.
- Safety profile: TEAEs mostly mild/moderate, resolving within 24h; SAE suicidal ideation <1% across both trials.
- Company requested FDA meeting to discuss rolling NDA submission for COMP360 in treatment-resistant depression.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816590/000181659026000007/0001816590-26-000007-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816590/000181659026000007/cmps-20260217.htm
  HTML page:      https://secwatch.observer/filing/0001816590-26-000007

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