Monitor for a formal BTD application or FDA feedback in upcoming filings; absence of material financial data or regulatory commitment makes near-term catalysts uncertain despite positive framing.
Price Chart
Executive Summary
Clearmind Medicine announced it is evaluating its lead candidate CMND-100 (MEAI) for potential FDA Breakthrough Therapy Designation based on positive Phase I/IIa clinical trial results for Alcohol Use Disorder. The company has not yet submitted a formal request, and the designation has not been granted.
Key Facts
- Clearmind is evaluating CMND-100 for FDA Breakthrough Therapy Designation (BTD) for treatment of Alcohol Use Disorder.
- BTD is reserved for drugs showing substantial improvement over existing therapies for serious conditions.
- The announcement is based on positive clinical results from an ongoing Phase I/IIa trial.
- No formal BTD application has been submitted, and no designation has been granted.
- The company cites a recent executive order by President Trump accelerating FDA review for psychedelic therapies as supportive context.
Financial Impact
No immediate financial impact disclosed; potential future upside if BTD is granted, which could accelerate development and commercialization.
Risk Factors
- No guarantee that CMND-100 will qualify for or receive Breakthrough Therapy Designation.
- Forward-looking statements dominate the release with no new clinical data or financial metrics provided.
- Low market cap ($2M) suggests high volatility and susceptibility to speculative trading on limited information.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-047736 |
| Document: ea0287806-6k_clearmind.htm | 0001213900-26-047736 |
| Document: 0001213900-26-047736-index-headers.html | 0001213900-26-047736 |
| Document: 0001213900-26-047736-index.html | 0001213900-26-047736 |
| Document: 0001213900-26-047736.txt | 0001213900-26-047736 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | 6-K | $5.92 | awaiting T+60 | — | $6.07 (+2.53%) |
Oct 27, 2026 today | Press Release | $6.50 | awaiting T+60 | — | $6.07 (−6.62%) |
Oct 16, 2026 11d ago | 6-K | $6.00 | awaiting T+60 | — | $6.07 (−1.17%) |
Oct 13, 2026 14d ago | 6-K | $6.23 | awaiting T+60 | — | $6.07 (−2.57%) |
Oct 8, 2026 19d ago | 6-K | $6.60 | awaiting T+60 | — | $6.07 (−8.03%) |
Oct 7, 2026 20d ago | 6-K | $6.60 | awaiting T+60 | — | $6.07 (−8.03%) |
Sep 23, 2026 4w ago | 6-K | $0.8500 | awaiting T+60 | — | $6.07 (+614.12%) |
Sep 23, 2026 4w ago | Press Release | $0.8500 | awaiting T+60 | — | $6.07 (+614.12%) |
Sep 17, 2026 5w ago | Press Release | $6.86 | awaiting T+60 | — | $6.07 (−11.57%) |
Sep 14, 2026 6w ago | 6-K | $0.9440 | awaiting T+60 | — | $6.07 (+543.01%) |
US Market Status
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