CLNN Clene Inc.
BULLISH
Impact: 8/10
8-K
8-K context-dependent: Items 7.01, 8.01
Latest settled — T+20d
CLNN ▼ -24.47% at T+20d
LONG call ✗ call lost -24.47% · α vs SPY -30.12% · entry $8.09 → $6.11
Last close $5.84 (close Jun 12) · -27.81% from $8.09 entry
T+1d
-18.66%
call -18.66% · α -19.46%
$6.58
settled 6w ago
T+5d
-19.65%
call -19.65% · α -22.59%
$6.50
settled 5w ago
T+20d
-24.47%
call -24.47% · α -30.12%
$6.11
settled 13d ago
T+60d
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call — · α —
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in 6w
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.
Actionable Insight
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.
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)
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 |
8 reports for CLNN
100%
Hit rate
best @ T+20▲ +19.55%
Filters
Rows
| Type | Now | ||||
|---|---|---|---|---|---|
|
May 14, 2026
4w ago
|
8-K
| $7.05 $6.81 | ▼ −3.40% | ▼ −2.69% | $5.84 (−17.16%) |
|
May 14, 2026
4w ago
|
Press Release
| $7.05 $6.81 | ▲ +3.40% | ▲ +2.69% | $5.84 (+17.16%) |
|
May 5, 2026
5w ago
|
424B5
| $7.16 $6.50 | ▲ +9.22% | ▲ +10.35% | $5.84 (+18.44%) |
|
May 4, 2026
5w ago
|
8-K
| $8.09 $6.50 | ▼ −19.65% | ▼ −22.59% | $5.84 (−27.81%) |
|
Apr 10, 2026
9w ago
|
DEFA14A
| $6.48 $6.15 | ▼ −5.09% | ▼ −8.39% | $5.84 (−9.88%) |
|
Mar 17, 2026
12w ago
|
8-K
| $6.13 $5.73 | ▼ −6.53% | ▼ −3.87% | $5.84 (−4.73%) |
|
Mar 12, 2026
13w ago
|
8-K
| $5.92 $5.87 | ▼ −0.84% | ▲ +0.13% | $5.84 (−1.35%) |
|
Mar 12, 2026
13w ago
|
Press Release
| $5.92 $5.87 | ▼ −0.84% | ▲ +0.13% | $5.84 (−1.35%) |
Showing 8 of 8
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