Summary
Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision
Clene NASDAQ: CLNN said it plans to submit a new drug application to the U.S. Food and Drug Administration at the beginning of the fourth quarter for CNM-Au8, its investigational treatment for amyotrophic lateral sclerosis, or ALS.
Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses
Clene NASDAQ: CLNN is preparing to submit a New Drug Application, or NDA, seeking accelerated approval for CNM-Au8 in amyotrophic lateral sclerosis, or ALS, after completing additional analyses requested by the U.S. Food and Drug Administration, President and CEO Rob Etherington said in an interview.
Clene Inc. (CLNN) Reports Q2 Loss, Beats Revenue Estimates
Clene Inc. (CLNN) came out with a quarterly loss of $0.6 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to a loss of $0.78 per share a year ago.
Clene Inc. Investors
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| CEA Craig Effron and Curtis Scoggin Management LP | 600,000 | $3.41M | $2.29M | -$1.12M | -32.81% |
| REF Robert E. Felty Penn Davis Mcfarland Inc | 11,000 | $33,880 | $42,680 | $8,800 | 25.97% |
| JC Jay Coppoletta PEAK6 LLC | 30,012 | $176,170.18 | $115,246.08 | -$60,924.1 | -34.58% |
| AB Andrew Blass Atlantic Private Wealth LLC | 2,205 | $10,120.95 | $8,401.05 | -$1,719.9 | -16.99% |
Clene Inc. (CLNN) FAQ
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Clene Inc. Profile
| Biotechnology Industry | Healthcare Sector | Robert Etherington CEO | NASDAQ (CM) Exchange | 185634201 CUSIP |
| US Country | 78 Employees | - Last Dividend | 11 Jul 2024 Last Split | 31 Dec 2020 IPO Date |
Overview
Clene Inc. is a clinical-stage pharmaceutical company that dedicates itself to the research, development, and potential commercialization of unique therapeutics based on clean-surfaced nanotechnology (CSN). Situated at the forefront of innovation in Salt Lake City, Utah, Clene has embarked on exploring the therapeutic potential of its lead drug, CNM-Au8, across a spectrum of debilitating diseases. The company's research endeavors focus on leveraging the unique properties of their CSN platforms to address conditions like amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson's disease, and various immunological and infectious diseases through a robust pipeline of clinical trials and product development strategies.
Products and Services
CNM-Au8:
- An ongoing array of clinical trials targets the application of CNM-Au8, focusing on debilitating neurological conditions. These include a Phase 2 trial for ALS safety and efficacy, early symptomatic ALS proof of concept, and studies aimed at understanding its impact on the brain's energy metabolites. Additionally, CNM-Au8 is under investigation for its potential to treat visual pathway deficits in chronic optic neuropathy for MS remyelination and Parkinson's Disease.
CNM-AgZn17:
- This product, a gel polymer suspension of silver and zinc ions, is in the development phase for treating infectious diseases and aiding wound healing. By leveraging the antimicrobial properties of silver and zinc, CNM-AgZn17 presents a promising approach to managing infections and supporting the body's natural healing processes.
CNM-ZnAg:
- As a broad-spectrum antiviral and antibacterial agent, CNM-ZnAg is designed to address infectious diseases and provide immune support for symptom resolution. Its broad-spectrum action showcases its potential utility in a wide range of infectious and immune-related conditions.
Dietary Supplements:
- The market presence of Clene extends into dietary supplements with two notable products. rMetx, an aqueous zinc-silver ion dietary supplement, and KHC46, an aqueous gold dietary supplement comprised of very low-concentration Au nanoparticles, both aim to provide health benefits rooted in the unique properties of their constituent metals.
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