Monitor for FDA feedback in Q2 2026, which will determine Phase 2 trial initiation. Positive clearance could catalyze investor interest given the first-in-class mechanism and unmet need in MS. Watch for interim Phase 2 data in Q4 2026 as a key value inflection point.
Price Chart
Executive Summary
Quantum Biopharma Ltd. (QNTM) announced the submission of an Investigational New Drug (IND) application to the FDA for its Lucid-MS candidate, targeting a Phase 2 clinical trial in multiple sclerosis. This marks a key advancement in its clinical pipeline, with FDA feedback expected in Q2 2026 and trial initiation planned shortly thereafter.
Key Facts
- Submitted IND application to the FDA for Lucid-MS, a first-in-class therapeutic targeting demyelination in multiple sclerosis.
- Phase 1 trials completed with favorable safety and tolerability profile in healthy participants.
- Anticipated FDA response in Q2 2026, with Phase 2 trial initiation planned in Q2 2026 and interim data projected for Q4 2026.
- Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation in preclinical models.
- Company retains 19.84% ownership in Unbuzzd Wellness Inc. and a 7% royalty on sales until $250 million is paid, then 3% in perpetuity.
Financial Impact
No direct financial figures disclosed. Potential long-term value from successful clinical development in a $38B global MS market by 2030.
Risk Factors
- FDA may not clear the IND, delaying or halting clinical development.
- Phase 2 trial may fail to demonstrate efficacy or safety despite positive Phase 1 results.
- Low market cap ($28M) increases volatility and susceptibility to dilution in future funding rounds.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001171843-26-002144 |
| Document: f6k_033126.htm | 0001171843-26-002144 |
| Document: 0001171843-26-002144-index-headers.html | 0001171843-26-002144 |
| Document: 0001171843-26-002144-index.html | 0001171843-26-002144 |
| Document: 0001171843-26-002144.txt | 0001171843-26-002144 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 8, 2026 19d ago | 6-K | $3.11 | awaiting T+20 | — | $2.32 (−25.40%) |
Oct 6, 2026 21d ago | 6-K | $3.09 | awaiting T+20 | — | $2.32 (−24.92%) |
Oct 6, 2026 21d ago | Press Release | $3.09 | awaiting T+20 | — | $2.32 (−24.92%) |
Oct 5, 2026 22d ago | SC 13G/A | $3.27 | awaiting T+20 | — | $2.32 (−29.05%) |
Sep 24, 2026 4w ago | 6-K | $4.00 $2.27 | ▼ −43.25% | ▼ −42.83% | $2.32 (−42.00%) |
Sep 17, 2026 5w ago | 6-K | $3.72 $2.71 | ▼ −27.15% | ▼ −28.36% | $2.32 (−37.63%) |
Sep 17, 2026 5w ago | 6-K | $3.72 $2.71 | ▼ −27.15% | ▼ −28.36% | $2.32 (−37.63%) |
Sep 15, 2026 6w ago | 6-K | $3.46 $2.89 | ▼ −16.47% | ▼ −19.45% | $2.32 (−32.95%) |
Sep 1, 2026 8w ago | 6-K | $3.08 $3.60 | ▲ +16.88% | ▲ +17.21% | $2.32 (−24.68%) |
Sep 1, 2026 8w ago | Press Release | $3.08 $3.60 | ▲ +16.88% | ▲ +17.21% | $2.32 (−24.68%) |
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