Welcome to our dedicated page for Clene news (Ticker: CLNN), a resource for investors and traders seeking the latest updates and insights on Clene stock.
Clene Inc. (Nasdaq: CLNN) generates a steady stream of news as a late clinical-stage biopharmaceutical company focused on neurodegenerative and neurological diseases. Company updates frequently center on its lead investigational therapy CNM-Au8, an oral suspension of gold nanocrystals designed to improve mitochondrial function, brain energy metabolism, and neuronal resilience in conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease (PD).
Investors and followers of CLNN news can expect detailed announcements on clinical trial results, biomarker analyses, and regulatory interactions. In ALS, Clene has reported statistically significant reductions in biomarkers like neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) with CNM-Au8 treatment, along with analyses linking biomarker changes to survival outcomes. News releases also cover FDA-recommended analyses, Type C meeting requests and outcomes, and the company’s plans for a potential New Drug Application under the accelerated approval pathway.
For MS and PD, Clene’s news includes Phase 2 data from REPAIR-MS and REPAIR-PD, where CNM-Au8 improved the brain NAD+/NADH ratio and related measures of energy metabolism, as well as preclinical PD data on mitochondrial health and cellular function. The company also issues regular financial and corporate updates, including quarterly results, equity distribution activity, convertible note agreements, and registered direct offerings that support its development and regulatory programs.
This CLNN news page aggregates these disclosures, from scientific conference presentations and investor webcasts to financing announcements and SEC-related communications. Readers who track Clene’s progress can use this feed to follow the evolution of CNM-Au8 across ALS, MS, and PD, monitor key regulatory milestones, and understand how new biomarker and survival data shape the company’s development strategy.
Clene (NASDAQ:CLNN) presented significant clinical data for CNM-Au8® at the ECTRIMS 2025 Congress, demonstrating improved brain energy metabolism in Multiple Sclerosis patients. The REPAIR-MS study showed a significant increase in brain NAD+/NADH ratio (+0.449 units, p=0.0148) after 12 weeks of treatment across all participants.
Key findings revealed that CNM-Au8® improved brain energy efficiency with a 9.49% increase in NAD+/NADH ratio in MS patients (p=0.0275). The study established important correlations between MS disease severity (EDSS scores) and brain energy metabolic deficits. The FDA has shown openness to considering alternative primary endpoints beyond EDSS, including cognitive measures, for future trials.
The treatment demonstrated a favorable safety profile, with mostly mild-to-moderate adverse events.
Clene (NASDAQ:CLNN) announced promising preclinical data for CNM-Au8® in treating Parkinson's disease (PD), presented at the Michael J Fox Foundation H2 Therapeutics Stewardship Meeting. The study utilized an innovative model converting skin cells from 8 sporadic PD patients, 14 familial PD patients, and 13 healthy individuals into dopaminergic neurons.
Key findings showed that CNM-Au8 treatment improved mitochondrial health, reduced inflammation, restored cellular metabolism, and normalized gene expression in PD neurons. The drug demonstrated favorable safety with over 1,000 patient-years of exposure data in ALS and MS patients. The company plans to design and implement a Phase 2 clinical study for PD treatment while advancing late-stage studies in ALS and MS.
Clene (NASDAQ:CLNN), a late clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City.
The company, which specializes in developing treatments for ALS and multiple sclerosis, will deliver a virtual presentation available for viewing on September 5, 2025. Management will also host one-on-one investor meetings during the conference. Investors can access the presentation through the company's website or register online for the webcast.
Clene (NASDAQ:CLNN) reported Q2 2025 financial results and provided updates on its CNM-Au8 development programs. The company has scheduled key FDA meetings to discuss its ALS treatment program, with plans to submit a New Drug Application (NDA) in Q4 2025 for potential accelerated approval.
Financial highlights include cash position of $7.3 million as of June 30, 2025, plus additional $3.4 million raised post-quarter, providing runway into Q1 2026. Q2 2025 showed reduced operating expenses, with R&D expenses at $3.5 million (down from $4.2M) and G&A expenses at $2.4 million (down from $3.3M). Net loss was $7.4 million ($0.78 per share).
The company presented promising MS treatment data at AAN 2025, showing significant improvements in cognition and visual function, with evidence of remyelination and neuronal repair in MS patients treated with CNM-Au8.
Clene (NASDAQ: CLNN), a clinical-stage biopharmaceutical company focused on neurodegenerative disease treatments, will present at the upcoming Emerging Growth Conference. The virtual presentation is scheduled for August 20, 2025, at 2:20 p.m. ET.
The corporate update will include a Q&A session and will be accessible through a webcast on Clene's website. A replay will be available through the conference portal and the Emerging Growth YouTube Channel after the event.
Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company specializing in neurodegenerative disease treatments, will present at the Canaccord 45th Annual Growth Conference on August 12th, 2025, at 3:30pm ET in Boston, MA.
The company, which focuses on developing treatments for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), will conduct a presentation and host one-on-one investor meetings. A webcast will be available through the company's website and online registration.
Clene (NASDAQ: CLNN) announced significant regulatory progress following a constructive FDA Type-C meeting regarding their neurofilament biomarker analysis plan. The company received supportive feedback on its statistical analysis plan (SAP) for comparing neurofilament light (NfL) biomarker data from its NIH-sponsored Expanded Access Protocol, which involves nearly 200 ALS patients treated with CNM-Au8®.
The company has scheduled two additional FDA meetings for Q3 2025: a Type C meeting to review long-term survival benefit data from CNM-Au8 treatment in ALS patients, and an End-of-Phase 2 Type B meeting to discuss MS program developments, particularly the Phase 2 VISIONARY-MS trial results and planned Phase 3 study.
Clene plans to conduct NfL analyses in early Q4 2025, with primary analysis at 9 months and supportive analysis at 6 months of treatment. If results show clinically meaningful NfL decline, the company aims to submit a new drug application (NDA) for ALS under the accelerated approval pathway by the end of 2025.
Clene Inc. (NASDAQ: CLNN) has announced its participation in the upcoming D. Boral Capital Inaugural Global Conference. The event will take place on May 14, 2025, at The Plaza Hotel in New York City. Rob Etherington, President and CEO of Clene, will be available for one-on-one meetings with interested parties from 9:00 A.M. to 3:00 P.M. (ET). Those interested in scheduling meetings can contact John Perez at jperez@dboralcapital.com.
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