secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2026-06-17T12:00:39+00:00
Accession:  0001493152-26-028992
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA submits Phase 2a protocol to FDA for Ketamir-2 in CIPN
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- Phase 2a protocol (Mira-002) for oral NMDA receptor modulator Ketamir-2 in chemotherapy-induced peripheral neuropathy.
- Randomized, double-blind, placebo-controlled, three-period crossover trial with 300 mg and 600 mg doses.
- No FDA-approved therapies exist for CIPN; study targets 30–40% of chemo patients affected.
- Phase 1 showed clean safety: no serious AEs or dose-limiting toxicities in 56 volunteers.
- Trial to run at a leading U.S. cancer center; FDA acknowledged receipt of submission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/0001493152-26-028992-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-028992

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