Monitor for IRB approval and site initiation updates in Q1 2027; the October scientific presentation and BioJapan participation may provide partnership or licensing signals.
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Executive Summary
MIRA Pharmaceuticals announced that its Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has been submitted for IRB review following FDA feedback, targeting site initiation in Q1 2027. This is a routine clinical-stage pipeline advancement with no financial data or efficacy results disclosed.
Key Facts
- Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review after FDA feedback
- Site initiation targeted for Q1 2027, subject to IRB approval and site activation
- Phase 2a is a randomized, double-blind, placebo-controlled crossover study with 300 mg and 600 mg doses
- Phase 1 in healthy volunteers showed no serious adverse events or dose-limiting toxicities
- Ketamir-2 is not classified as a controlled substance by the DEA
- Company also plans to present Ketamir-2 data at a conference in Tokyo (Oct 5-6, 2026) and participate in BioJapan for licensing discussions
Financial Impact
No financial figures disclosed; pre-revenue clinical-stage company
Risk Factors
- Clinical trial failure or disappointing efficacy/safety data in Phase 2a
- Delays in IRB approval or site initiation beyond Q1 2027 guidance
- No FDA-approved therapies specifically for CIPN exist, but competitive landscape includes off-label treatments
- Company is pre-revenue and will require additional financing to complete development
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-043051 |
| Exhibit: ex99-1.htm | 0001493152-26-043051 |
| Document: 0001493152-26-043051-index-headers.html | 0001493152-26-043051 |
| Document: 0001493152-26-043051-index.html | 0001493152-26-043051 |
| Document: 0001493152-26-043051.txt | 0001493152-26-043051 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 4d ago | 8-K | $0.6290 $0.6195 | ▼ −1.51% | ▼ −0.99% | $0.5328 (−15.29%) |
Oct 22, 2026 4d ago | Press Release | $0.6289 $0.6195 | ▼ −1.49% | ▼ −0.97% | $0.5328 (−15.28%) |
Sep 17, 2026 5w ago | 8-K | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5328 (−29.83%) |
Sep 17, 2026 5w ago | Press Release | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5328 (−29.83%) |
Sep 1, 2026 7w ago | 8-K | $0.8600 $0.8495 | ▼ −1.22% | ▼ −1.66% | $0.5328 (−38.05%) |
Aug 6, 2026 11w ago | 8-K | $0.6782 $0.7400 | ▲ +9.11% | ▲ +8.50% | $0.5328 (−21.44%) |
Jul 10, 2026 15w ago | 8-K | $0.9245 $0.9097 | ▼ −1.60% | ▼ −0.84% | $0.5328 (−42.37%) |
Jul 6, 2026 16w ago | 8-K | $0.9549 $0.9478 | ▼ −0.74% | ▼ −0.27% | $0.5328 (−44.20%) |
Jun 17, 2026 18w ago | 8-K | $0.9782 $0.9524 | ▼ −2.64% | ▼ −3.42% | $0.5328 (−45.53%) |
Jun 8, 2026 20w ago | 8-K | $0.9767 $0.9802 | ▲ +0.36% | ▲ +1.93% | $0.5328 (−45.45%) |
US Market Status
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