Company Profile

Clene Inc. Stock Price, News & Analysis

Ticker:
CLNN
Exchange:
NASDAQ
Sector:
Biopharma
Location:
United States

Stock performance

5.34 USD (-0.74%)

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Last updated: August 6, 2026

75M USD

Market cap

Why the stock is moving

As of Aug 6, 2026, CLNN closed down 0.74% at $5.34. No new same-company headline was identified in the current news window.

Company overview

Late-Stage Neurodegenerative Disease Company

Clene is a late clinical-stage biopharmaceutical company developing therapies that improve mitochondrial health and preserve neurological function in diseases including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis.

CNM-Au8 Mechanism

CNM-Au8 is a first-in-class oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, support mitochondrial function and the NAD pathway, reduce oxidative stress, and restore or protect central nervous system cells.

Accelerated Approval Path in ALS

Following a Type C meeting, the FDA indicated that the proposed evidence may support submission and review of an NDA for CNM-Au8 in ALS under the Accelerated Approval pathway. The package centers on reductions in neurofilament light and the relationship between that biomarker response and clinical benefit, particularly survival.

Biomarker-Led Regulatory Strategy

Clene is using neurofilament light as a marker of neuroaxonal injury and treatment effect. The regulatory case depends on demonstrating that biomarker reductions are reasonably likely to predict clinical benefit and are supported by survival observations across the CNM-Au8 dataset.

Broader Neurodegeneration Platform

The mitochondrial and cellular-energy mechanism underlying CNM-Au8 is also being explored in multiple sclerosis and Parkinson’s disease. ALS is the lead regulatory opportunity, while the broader pipeline tests whether the same mechanism can support several neurodegenerative conditions.

Future catalysts

An NDA for CNM-Au8 in ALS is expected to be submitted under the Accelerated Approval pathway in the third quarter of 2026.

The confirmatory Phase 3 RESTORE-ALS study is planned to begin in the first quarter of 2027, with survival improvement as the primary endpoint.

Recent news

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    Clene to Present at Upcoming May Conferences

    Source: Clene Inc.

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Frequently Asked Questions

What is the current stock price of Clene Inc. (CLNN)?

Clene Inc. (CLNN) most recently closed at 5.34 USD, a -0.74% move versus the previous session.

What is the market cap of Clene Inc. (CLNN)?

Clene Inc. currently has a market capitalization of 75M USD on BioPharmSignal.

What does Clene Inc. do?

Late-Stage Neurodegenerative Disease Company Clene is a late clinical-stage biopharmaceutical company developing therapies that improve mitochondrial health and preserve neurological function in diseases including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8 Mechanism CNM-Au8 is a first-in-class oral suspension of gold...

On which exchange is CLNN stock listed?

Clene Inc. (CLNN) is associated with NASDAQ, United States, Biopharma.

What is RESTORE-ALS?

The confirmatory Phase 3 RESTORE-ALS study is planned to begin in the first quarter of 2027, with survival improvement as the primary endpoint.

Which conditions is Clene Inc. targeting with RESTORE-ALS?

The confirmatory Phase 3 RESTORE-ALS study is planned to begin in the first quarter of 2027, with survival improvement as the primary endpoint.

How does Clene Inc. describe recent progress with RESTORE-ALS?

The confirmatory Phase 3 RESTORE-ALS study is planned to begin in the first quarter of 2027, with survival improvement as the primary endpoint.

What is Late-Stage?

Late-Stage Neurodegenerative Disease Company Clene is a late clinical-stage biopharmaceutical company developing therapies that improve mitochondrial health and preserve neurological function in diseases including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis.