secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2026-02-02T23:59:59+00:00
Accession:  0001493152-26-004739
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA Pharma initiates final cohort of Ketamir-2 Phase 1 MAD trial; 50 volunteers dosed
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- Phase 1 MAD trial final cohort dosing underway; 50 healthy volunteers dosed, 6 remaining; completion expected by Q1 2026.
- Phase 2a proof-of-concept study for CIPN planned; protocol submission to FDA after Phase 1; targeting Q2 2026 start.
- Plans to pursue FDA Fast Track designation for Ketamir-2; to present Phase 1 data at AACR April 2026.
- Preclinical programs SKNY-1 (weight loss/nicotine addiction) and MIRA-55 (inflammatory pain) advancing toward IND-enabling by year-end 2026.
- Engaging in partnering discussions at BIO Partnering Investment & Growth Summit in March 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226004739/0001493152-26-004739-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226004739/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-004739

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