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) is a clinical-stage biopharmaceutical leader developing novel nanocrystal therapies for neurodegenerative diseases. This page provides investors and researchers with essential updates on Clene’s progress in treating ALS, multiple sclerosis, and Parkinson’s disease through its innovative Clean-Surface Nanocrystal (CSN) platform.
Find authoritative coverage of Clene’s clinical trials, including updates on lead candidate CNM-Au8®’s impact on mitochondrial health and oxidative stress biomarkers. Track regulatory developments, partnership announcements with research institutions, and analyses of trial data from Phase 2/3 studies. Our curated news collection helps stakeholders monitor Clene’s unique approach to neurodegeneration through nanotechnology.
Key updates include progress toward FDA submissions, Expanded Access Program results, and peer-reviewed research publications. Bookmark this page for real-time access to earnings reports, strategic collaborations, and scientific presentations that demonstrate Clene’s position at the forefront of neurotherapeutic innovation.
Clene (Nasdaq: CLNN) announced management will present a corporate update at the Emerging Growth Conference on December 10, 2025 at 4:25 p.m. ET. The presentation will be virtual and a live webcast will be available on the company Events page and through the conference portal. A replay will be posted on the Emerging Growth YouTube channel after the event. The presentation covers company developments related to Clene's clinical-stage programs in neurodegenerative diseases including ALS and MS.
Clene (Nasdaq: CLNN) announced FDA‑recommended biomarker analyses for CNM‑Au8 in ALS showing statistically significant reductions in NfL and GFAP, strong correlation between the two (Pearson's r >0.85, p<0.0001), and biomarker declines linked to improved survival.
Key figures: NIH‑EAP Week 36 NfL AUC GMR 0.914 (p=0.0373); HEALEY 1‑year Cox HR in FAS 0.2723 (73% risk reduction, p=0.0144) and in CRS 0.229 (77% reduction, p=0.0151); placebo‑to‑CNM‑Au8 RMST +30.7 days at one year (p=0.0094). Company requested a Type C meeting and plans an accelerated approval NDA submission in Q1 2026. Safety: no investigator‑related SAEs across >1,000 patient‑years.
Clene (Nasdaq: CLNN) will host a CNM-Au8 ALS program update webcast and investor call on December 3, 2025 at 8:30 a.m. ET.
Presenters include Rob Etherington (CEO and President), Dr. Ben Greenberg (Head of Medical), Michael Hotchkin (Chief Development Officer) and a key opinion leader. The live webcast link and dial‑in numbers are provided for U.S. and international participants, and an archived webcast will be available on the company website approximately two hours after the event.
Clene (Nasdaq: CLNN) announced management will participate in the Benchmark 14th Annual Discovery One-on-One Investor Conference and host 1x1 investor meetings on December 4, 2025 in New York, New York. Meetings are by appointment via Benchmark representatives. The company and its subsidiary Clene Nanomedicine focus on mitochondrial health and neuronal protection for neurodegenerative diseases, including ALS and MS.
Clene (Nasdaq: CLNN) reported third quarter 2025 results and operational updates on CNM-Au8 programs for ALS, MS, and PD.
The company had $7.9M cash as of Sept 30, 2025, and says additional $1.2M raised extends runway into Q2 2026. Clene plans an NDA filing in Q1 2026 under an accelerated approval pathway, expects first patient dosing in the confirmatory Phase 3 RESTORE-ALS trial in H1 2026, and will request a Type C FDA meeting to review further ALS biomarker analyses in Q1 2026.
Clene (Nasdaq: CLNN) will present a corporate update at the Emerging Growth Conference on October 23, 2025 at 3:10 p.m. ET. The company and its subsidiary Clene Nanomedicine, a clinical-stage biopharmaceutical focused on mitochondrial health and treatments for neurodegenerative diseases including ALS and MS, will deliver the virtual presentation.
A live webcast and accompanying slides will be available via the Events section of Clene's website and by registration at the provided webcast link. A replay will be posted on the conference portal and the Emerging Growth YouTube channel after the event.
Clene (Nasdaq: CLNN) said management will participate in a panel discussion at the Maxim Growth Summit and will host 1x1 investor meetings on October 22, 2025 in New York City. The panel is titled Neurodegenerative Diseases Panel – Under the Radar Innovators in One of the Most Challenging Therapeutic Categories. Meeting requests for 1x1 sessions are available through a Maxim representative.
The company and its subsidiary Clene Nanomedicine focus on mitochondrial health and neuronal protection for diseases including ALS and MS.
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.
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