secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2025-07-28T23:59:59+00:00
Accession:  0001641172-25-021155
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA Pharma receives FDA IND clearance for Ketamir-2, advancing neuropathic pain program
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- FDA cleared IND for Ketamir-2, an oral NMDA antagonist for neuropathic pain, enabling U.S. clinical trials.
- Preclinical head-to-head data showed superior efficacy to gabapentin and pregabalin with no ketamine-related neurotoxicity.
- Phase 1 single ascending dose portion nearing completion; U.S. Phase 2a efficacy trial planned for Q4 2025.
- Acquisition of SKNY Pharmaceuticals on track; SKNY-1 shows efficacy in obesity and nicotine craving models.
- MIRA-55 oral cannabinoid analog demonstrated comparable efficacy to morphine in inflammatory pain models.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/0001641172-25-021155-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-021155

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