Monitor for FDA feedback on the Phase 2a protocol and subsequent trial initiation. The clean Phase 1 safety profile and large unmet need in CIPN support the program, but clinical-stage biotech carries high execution risk. No near-term revenue catalyst.
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Executive Summary
MIRA Pharmaceuticals announced the submission of a Phase 2a clinical trial protocol to the FDA for Ketamir-2, its oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN). The FDA acknowledged receipt. The planned randomized, double-blind, placebo-controlled crossover study will evaluate safety, tolerability, and dose-response at 300 mg and 600 mg doses at a leading U.S. cancer center, building on a clean Phase 1 safety profile. No financial data or guidance was provided.
Key Facts
- Submitted Phase 2a protocol (Mira-002) to FDA for Ketamir-2 in CIPN
- FDA acknowledged receipt of the protocol submission
- Phase 2a is a randomized, double-blind, placebo-controlled, three-period crossover trial with 300 mg and 600 mg doses
- Phase 1 (MIRA-001) enrolled 56 healthy volunteers with no serious adverse events or dose-limiting toxicities
- No FDA-approved therapies exist specifically for CIPN; estimated 3 million new persistent cases annually worldwide
- Ketamir-2 is an oral NMDA receptor modulator, non-scheduled by DEA, with IP in 10 major markets
Financial Impact
No financial figures disclosed; clinical-stage company with $40M market cap
Risk Factors
- Clinical trial failure or delays
- Need for additional financing to complete Phase 2a
- Regulatory hurdles or negative FDA feedback on protocol
- Competition from off-label treatments (gabapentin, duloxetine)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-028992 |
| Exhibit: ex99-1.htm | 0001493152-26-028992 |
| Document: 0001493152-26-028992-index-headers.html | 0001493152-26-028992 |
| Document: 0001493152-26-028992-index.html | 0001493152-26-028992 |
| Document: 0001493152-26-028992.txt | 0001493152-26-028992 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 5d ago | 8-K | $0.6290 $0.6195 | ▼ −1.51% | ▼ −0.99% | $0.5500 (−12.56%) |
Oct 22, 2026 5d ago | Press Release | $0.6289 $0.6195 | ▼ −1.49% | ▼ −0.97% | $0.5500 (−12.55%) |
Sep 17, 2026 5w ago | 8-K | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5500 (−27.56%) |
Sep 17, 2026 5w ago | Press Release | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5500 (−27.56%) |
Sep 1, 2026 8w ago | 8-K | $0.8600 $0.8495 | ▼ −1.22% | ▼ −1.66% | $0.5500 (−36.05%) |
Aug 6, 2026 11w ago | 8-K | $0.6782 $0.7400 | ▲ +9.11% | ▲ +8.50% | $0.5500 (−18.90%) |
Jul 10, 2026 15w ago | 8-K | $0.9245 $0.9097 | ▼ −1.60% | ▼ −0.84% | $0.5500 (−40.51%) |
Jul 6, 2026 16w ago | 8-K | $0.9549 $0.9478 | ▼ −0.74% | ▼ −0.27% | $0.5500 (−42.40%) |
Jun 17, 2026 18w ago | 8-K | $0.9782 $0.9524 | ▼ −2.64% | ▼ −3.42% | $0.5500 (−43.77%) |
Jun 8, 2026 20w ago | 8-K | $0.9767 $0.9802 | ▲ +0.36% | ▲ +1.93% | $0.5500 (−43.69%) |
US Market Status
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