The clinical hold is a binary event for QNTM given the $34M market cap and Lucid-MS as the lead asset. Watch for the company's response package submission and FDA feedback; the hold duration is unpredictable. The director resignation adds governance uncertainty. Consider the stock at risk of significant downside until the hold is resolved.
Price Chart
Executive Summary
Quantum BioPharma disclosed that the FDA placed its lead drug candidate Lucid-MS (for multiple sclerosis) on clinical hold on May 28, 2026, pending additional information. The company is withdrawing previously disclosed timelines for Phase 2 trial initiation and interim data. Additionally, director Dr. Lakshmi P. Kotra resigned effective June 1, 2026. This is a material negative regulatory setback for the company's primary pipeline asset.
Key Facts
- FDA placed IND for Lucid-MS (Lucid-21-302) on clinical hold on May 28, 2026
- Company withdrawing previously disclosed timelines for Phase 2 trial initiation and interim data milestones
- Director Dr. Lakshmi P. Kotra resigned from all positions effective June 1, 2026
- Company believes issues are addressable and plans to submit a response package
- Market cap is $34M — clinical hold on lead asset represents a major binary risk event
Financial Impact
No financial figures reported; clinical hold on lead drug candidate Lucid-MS places the company's primary value driver at risk and delays any potential revenue timeline indefinitely
Risk Factors
- Clinical hold may remain in place for a prolonged period or may not be lifted
- Additional studies or data may be required beyond current scope, increasing cash burn
- Director resignation signals potential internal challenges
- Withdrawn timelines create a valuation vacuum — no near-term catalysts
- Pre-revenue biotech with no approved products; dependent on financing for operations
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001185185-26-002283 |
| Document: qntm6k060226.htm | 0001185185-26-002283 |
| Document: 0001185185-26-002283-index-headers.html | 0001185185-26-002283 |
| Document: 0001185185-26-002283-index.html | 0001185185-26-002283 |
| Document: 0001185185-26-002283.txt | 0001185185-26-002283 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 8, 2026 18d ago | 6-K | $3.11 | awaiting T+20 | — | $2.21 (−28.94%) |
Oct 6, 2026 20d ago | 6-K | $3.09 | awaiting T+20 | — | $2.21 (−28.48%) |
Oct 6, 2026 20d ago | Press Release | $3.09 | awaiting T+20 | — | $2.21 (−28.48%) |
Oct 5, 2026 21d ago | SC 13G/A | $3.27 | awaiting T+20 | — | $2.21 (−32.42%) |
Sep 24, 2026 4w ago | 6-K | $4.00 $2.27 | ▼ −43.25% | ▼ −42.83% | $2.21 (−44.75%) |
Sep 17, 2026 5w ago | 6-K | $3.72 $2.71 | ▼ −27.15% | ▼ −28.36% | $2.21 (−40.59%) |
Sep 17, 2026 5w ago | 6-K | $3.72 $2.71 | ▼ −27.15% | ▼ −28.36% | $2.21 (−40.59%) |
Sep 15, 2026 5w ago | 6-K | $3.46 $2.89 | ▼ −16.47% | ▼ −19.45% | $2.21 (−36.13%) |
Sep 1, 2026 7w ago | 6-K | $3.08 $3.60 | ▲ +16.88% | ▲ +17.21% | $2.21 (−28.25%) |
Sep 1, 2026 7w ago | Press Release | $3.08 $3.60 | ▲ +16.88% | ▲ +17.21% | $2.21 (−28.25%) |
US Market Status
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