# Clene Inc. (CLNN) Stock Price, News & Catalysts
Canonical URL: https://biopharmsignal.com/company/CLNN
## Company Profile
- Ticker: CLNN
- Exchange: NASDAQ
- Sector: Biopharma
- Location: United States
- Tags: CNS
## Stock Data
- Close: 4.07 USD
- Market cap: 75008662.09 USD
- Last updated: 2026-08-12
## Business 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.
## Why The Stock Is Moving

As of Aug 12, 2026, CLNN closed down 6.86% at $4.07. No new same-company headline was identified in the current news window.

## 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
- 2026-08-10 12:00 EST — [Clene Announces Biomarker Analyses To Be Included in NDA Submission Supporting ALS Accelerated Approval](https://biopharmsignal.com/news/CLNN/clene-announces-biomarker-analyses-to-be-included-in-nda-submission-supporting-a-950bb173) — Source: Clene Inc.
- 2026-07-29 12:30 EST — [Clene to Present at The Canaccord 46th Annual Growth Conference](https://biopharmsignal.com/news/CLNN/clene-to-present-at-the-canaccord-46th-annual-growth-conference-2a84d8af) — Source: Clene Inc.
- 2026-05-14 12:00 EST — [Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights](https://biopharmsignal.com/news/CLNN/clene-reports-first-quarter-2026-financial-results-and-recent-operating-highligh-05f09938) — Source: Clene Inc.
- 2026-05-05 12:45 EST — [Clene Announces $7 Million Underwritten Offering of Common Stock](https://biopharmsignal.com/news/CLNN/clene-announces-7-million-underwritten-offering-of-common-stock-ea05bb73) — Source: Clene Inc.
- 2026-05-05 12:00 EST — [Clene to Present at Upcoming May Conferences](https://biopharmsignal.com/news/CLNN/clene-to-present-at-upcoming-may-conferences-e4de6669) — Source: Clene Inc.