secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2025-08-19T23:59:59+00:00
Accession:  0001641172-25-024731
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA Pharmaceuticals completes Phase 1 SAD for Ketamir-2; no safety issues, advances to MAD
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- Completed SAD phase with 32 participants across 4 cohorts (50-600 mg); no severe adverse effects observed.
- Advancing to MAD phase with 3 cohorts (150, 300, 600 mg daily for 5 days) in up to 24 participants.
- FDA IND clearance for neuropathic pain already received; U.S. Phase 2a trial planned for Q4 2025.
- Safety monitored via C-SSRS, Bowdle VAS, and KSET scales; no clinically significant safety concerns.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000164117225024731/0001641172-25-024731-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000164117225024731/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-024731

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