secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2024-12-19T23:59:59+00:00
Accession:  0001493152-24-050695
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA submits IND for Ketamir-2 (neuropathic pain) to FDA; Phase I expected Q1 2025
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- IND submitted to FDA on Dec 19, 2024 for Ketamir-2, a novel oral ketamine analog.
- Phase I clinical trials expected to start Q1 2025; Phase IIa planned for late 2025.
- Preclinical data showed full pain reversal with no adverse safety findings.
- Ketamir-2 targets unmet needs in neurological disorders and neuropathic pain.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315224050695/0001493152-24-050695-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315224050695/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-050695

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