secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2026-03-03T23:59:59+00:00
Accession:  0001493152-26-008707
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA completes Phase 1 dosing of Ketamir-2; no serious AEs; plans Phase 2a in CIPN
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- Completed Phase 1 study in 56 healthy volunteers; no serious adverse events or dose-limiting toxicities.
- No clinically significant dissociative or psychotomimetic effects typically seen with ketamine observed.
- Plans to submit Phase 2a proof-of-concept study to FDA in H1 2026 for chemotherapy-induced peripheral neuropathy (CIPN).
- CIPN lacks FDA-approved therapies; Ketamir-2 is a selective oral NMDA receptor modulator.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226008707/0001493152-26-008707-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226008707/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-008707

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