secwatch.observer — SEC 8-K summary
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Issuer:     Incannex Healthcare Inc. (IXHL)
CIK:        0001873875
Form:       8-K
Filed at:   2025-08-26T23:59:59+00:00
Accession:  0001213900-25-080509
Event type: other_material
Sentiment:  positive
Materiality: 1.00
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Incannex reports positive Phase 2 results for PSX-001 in Generalized Anxiety Disorder
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- Psi-GAD (PSX-001) achieved a 12.8-point HAM-A reduction vs. 3.6 for placebo (p<0.0001) over 11 weeks.
- 44.1% of patients had clinical response (≥50% HAM-A reduction) and 27% achieved full remission (HAM-A ≤7).
- GAD-7 scores fell 7.4 points, SDS improved 6.0 points, PHQ-9 dropped 3.9 points, all statistically significant.
- No serious adverse events reported; only one subject withdrew from the 73-participant trial.
- Incannex plans a multi-jurisdiction Phase 2 trial and is exploring strategic partnerships for PSX-001.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1873875/000121390025080509/0001213900-25-080509-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1873875/000121390025080509/ea0254452-8k_incannex.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-080509

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