Monitor for IRB approval and site initiation in Q1 2027. The October conference presentation and BioJapan participation may provide partnership or licensing updates, but no near-term binary catalyst is identified.
Price Chart
Executive Summary
MIRA Pharmaceuticals announced submission of its Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) to IRB review, targeting site initiation in Q1 2027. The press release provides no financial data, no regulatory decision, and no catalyst date — only a routine clinical development update for an early-stage biotech.
Key Facts
- Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review at a leading cancer research institution
- Site initiation targeted for Q1 2027, subject to IRB approval and site activation
- Phase 2a is a randomized, double-blind, placebo-controlled, three-period crossover study with 300 mg and 600 mg doses
- Ketamir-2 completed Phase 1 with favorable safety, tolerability, and PK profile; no serious adverse events or dose-limiting toxicities
- No FDA-approved therapies specifically indicated for CIPN
- Ketamir-2 is not classified as a controlled substance by the DEA
- MIRA expects to present Ketamir-2 at a conference in Tokyo on October 5–6, 2026
- MIRA also expects to participate in BioJapan in October for licensing and partnership discussions
Financial Impact
No financial data provided in the press release
Risk Factors
- Clinical trial enrollment and execution risks for Phase 2a
- No guarantee of positive efficacy data in CIPN
- Early-stage biotech with no approved products or revenue
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3363977 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 5d ago | 8-K | $0.6290 $0.6195 | ▼ −1.51% | ▼ −0.99% | $0.5600 (−10.97%) |
Oct 22, 2026 5d ago | Press Release | $0.6289 $0.6195 | ▼ −1.49% | ▼ −0.97% | $0.5600 (−10.96%) |
Sep 17, 2026 5w ago | 8-K | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5600 (−26.25%) |
Sep 17, 2026 5w ago | Press Release | $0.7593 $0.8323 | ▲ +9.61% | ▲ +9.73% | $0.5600 (−26.25%) |
Sep 1, 2026 8w ago | 8-K | $0.8600 $0.8495 | ▼ −1.22% | ▼ −1.66% | $0.5600 (−34.88%) |
Aug 6, 2026 11w ago | 8-K | $0.6782 $0.7400 | ▲ +9.11% | ▲ +8.50% | $0.5600 (−17.43%) |
Jul 10, 2026 15w ago | 8-K | $0.9245 $0.9097 | ▼ −1.60% | ▼ −0.84% | $0.5600 (−39.43%) |
Jul 6, 2026 16w ago | 8-K | $0.9549 $0.9478 | ▼ −0.74% | ▼ −0.27% | $0.5600 (−41.36%) |
Jun 17, 2026 18w ago | 8-K | $0.9782 $0.9524 | ▼ −2.64% | ▼ −3.42% | $0.5600 (−42.75%) |
Jun 8, 2026 20w ago | 8-K | $0.9767 $0.9802 | ▲ +0.36% | ▲ +1.93% | $0.5600 (−42.66%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers