Monitor for the planned IND submission in Q1 2027 and any subsequent Phase 1 clinical trial initiation. The positive preclinical data de-risks the program but human data is still needed.
Price Chart
Executive Summary
MIRA Pharmaceuticals reported positive preclinical results for MIRA-55, an oral synthetic cannabinoid analog for chronic inflammatory pain. A 21-day IND-enabling study showed pain relief comparable to Celebrex with sustained efficacy and no observed tolerance. The company plans an IND submission in Q1 2027.
Key Facts
- MIRA-55 demonstrated significant pain relief vs vehicle (p < 0.001) in a 21-day chronic inflammatory pain model.
- Pain-relieving effects were comparable in magnitude to celecoxib (Celebrex).
- Efficacy was sustained for 3 weeks without evidence of tolerance.
- MIRA-55 reduced inflammation-associated paw swelling to a similar magnitude as celecoxib.
- Consistent pain-relieving activity was observed in both male and female animals.
- No adverse clinical signs or deaths were reported; normal body-weight gain was maintained.
- Planned IND submission in Q1 2027.
- The DEA has determined MIRA-55 is not a controlled substance.
- 72 male and female rats were used in the study.
Financial Impact
No financial data provided in the filing. The event is a preclinical data readout with no revenue or earnings impact.
Risk Factors
- Preclinical results may not translate to human efficacy or safety.
- IND submission and clinical development timelines may be delayed.
- MIRA-55 remains in preclinical development; safety and efficacy in humans have not been established.
- The company is a clinical-stage biotech with no approved products and likely requires additional financing to fund development.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-048022 |
| Exhibit: ex99-1.htm | 0001493152-26-048022 |
| Document: 0001493152-26-048022-index-headers.html | 0001493152-26-048022 |
| Document: 0001493152-26-048022-index.html | 0001493152-26-048022 |
| Document: 0001493152-26-048022.txt | 0001493152-26-048022 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 5d ago | 8-K | $0.6290 $0.6195 | ▼ −1.51% | ▼ −0.99% | $0.5330 (−15.26%) |
Oct 22, 2026 5d ago | Press Release | $0.6289 $0.6195 | ▼ −1.49% | ▼ −0.97% | $0.5330 (−15.25%) |
Sep 17, 2026 5w ago | 8-K | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5330 (−29.80%) |
Sep 17, 2026 5w ago | Press Release | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5330 (−29.80%) |
Sep 1, 2026 8w ago | 8-K | $0.8600 $0.8495 | ▼ −1.22% | ▼ −1.66% | $0.5330 (−38.02%) |
Aug 6, 2026 11w ago | 8-K | $0.6782 $0.7400 | ▲ +9.11% | ▲ +8.50% | $0.5330 (−21.41%) |
Jul 10, 2026 15w ago | 8-K | $0.9245 $0.9097 | ▼ −1.60% | ▼ −0.84% | $0.5330 (−42.35%) |
Jul 6, 2026 16w ago | 8-K | $0.9549 $0.9478 | ▼ −0.74% | ▼ −0.27% | $0.5330 (−44.18%) |
Jun 17, 2026 18w ago | 8-K | $0.9782 $0.9524 | ▼ −2.64% | ▼ −3.42% | $0.5330 (−45.51%) |
Jun 8, 2026 20w ago | 8-K | $0.9767 $0.9802 | ▲ +0.36% | ▲ +1.93% | $0.5330 (−45.43%) |
US Market Status
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