8-K ·Filed May 4, 2026
8-K context-dependent: Items 7.01, 8.01
Actionable Insight ▲ Bullish
Expect strong price reaction on this regulatory catalyst. Monitor for NDA submission details and any financing announcements given $72M market cap. Prior insider selling may be less relevant post-news.
Final — all horizons settled through T+60d
CLNN ▼ -41.66% at T+60d
LONG call ✗ call lost -41.66% · α vs SPY -43.51% · entry $8.09 → $4.72
T+1d
-18.66%
call -18.66% · α -19.46%
$6.58
settled 6mo ago
T+5d
-19.65%
call -19.65% · α -22.59%
$6.50
settled 6mo ago
T+20d
-24.47%
call -24.47% · α -30.12%
$6.11
settled 5mo ago
T+60d
-41.66%
call -41.66% · α -43.51%
$4.72
settled 3mo ago
Price Chart
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Executive Summary
Clene Inc. announces FDA agreement that its CNM-Au8 data may support accelerated approval NDA for ALS, with submission planned for Q3 2026. This is a major regulatory milestone for a $72M market cap biotech.
Key Facts
- FDA stated proposed data may be capable of supporting accelerated approval NDA for CNM-Au8 in ALS
- FDA acknowledged NfL could serve as reasonably likely surrogate endpoint
- NDA submission planned for Q3 2026
- Phase 3 confirmatory study expected to commence Q1 2027
- CNM-Au8 has Orphan Drug Designation for ALS
- Data from Phase 2 HEALEY ALS Platform Trial, RESCUE-ALS, and NIH Expanded Access Protocol support submission
Financial Impact
Potential FDA approval could unlock significant value; no financial data in filing
Risk Factors
- FDA may not accept NDA or require additional data
- Accelerated approval not guaranteed; confirmatory trial needed for full approval
- Company likely needs additional capital to fund operations and trials, potential dilution
Market Snapshot
Exchange
Nasdaq
Sector
Pharmaceutical Preparations
Analyst Consensus
92% bullish (12 analysts)
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-014542 |
| Exhibit: ex_955500.htm | 0001437749-26-014542 |
| Document: 0001437749-26-014542-index-headers.html | 0001437749-26-014542 |
| Document: 0001437749-26-014542-index.html | 0001437749-26-014542 |
| Document: 0001437749-26-014542.txt | 0001437749-26-014542 |
17 reports for CLNN
86% Hit rate @ T+20 Went positive at some point 8 of 9 best @ T+60▲ +29.96%
Filters
Rows
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 6d ago | 8-K | $3.73 | awaiting T+20 | — | $3.84 (+2.95%) |
Oct 19, 2026 7d ago | 8-K | $3.29 | awaiting T+20 | — | $3.84 (+16.72%) |
Oct 19, 2026 7d ago | Press Release | $3.29 | awaiting T+20 | — | $3.84 (+16.72%) |
Oct 13, 2026 13d ago | SC 13G/A | $3.39 | awaiting T+20 | — | $3.84 (+13.27%) |
Sep 16, 2026 5w ago | 8-K | $4.15 $3.31 | ▲ +20.36% | ▲ +21.57% | $3.84 (+7.47%) |
Sep 16, 2026 5w ago | 424B5 | $3.86 $3.31 | ▲ +14.25% | ▲ +16.31% | $3.84 (+0.52%) |
Aug 14, 2026 10w ago | 8-K | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.84 (−7.25%) |
Aug 14, 2026 10w ago | Press Release | $4.14 $3.28 | ▼ −20.77% | ▼ −18.78% | $3.84 (−7.25%) |
Aug 10, 2026 11w ago | 8-K | $5.16 $3.62 | ▼ −29.84% | ▼ −28.93% | $3.84 (−25.58%) |
May 14, 2026 23w ago | 8-K | $7.05 $5.84 | ▼ −17.16% | ▼ −16.30% | $3.84 (−45.53%) |
Showing 10 of 17
US Market Status
Market Closed — Opens Tue (15h 56m)
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