secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2026-09-17T12:30:40+00:00
Accession:  0001493152-26-043051
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA advances Ketamir-2 Phase 2a for CIPN; IRB submission after FDA review, site initiation targeted Q1 2027
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- Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review after incorporating FDA feedback; site initiation targeted Q1 2027.
- Randomized, double-blind, placebo-controlled three-period crossover; Ketamir-2 300 mg and 600 mg vs placebo; 7-day periods with 13-day washouts.
- Builds on completed Phase 1 in healthy volunteers with favorable safety/PK profile; no serious adverse events or dose-limiting toxicities.
- No FDA-approved therapies specifically indicated for CIPN; Ketamir-2 is not a DEA-controlled substance.
- MIRA to present Ketamir-2 data at Tokyo conference Oct 5-6, 2026 and attend BioJapan for licensing discussions.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/0001493152-26-043051-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-043051

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