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) management will present a corporate update at the Emerging Growth Conference on January 21, 2026 at 3:10 p.m. ET. The presentation is virtual and will be webcast; live access is available via registration at the provided webcast link and from the Events section of the Clene website. A replay will be available after the event through the conference portal and the Emerging Growth YouTube channel. The conference hosts video webcasts in Eastern Time and targets individual and institutional investors, advisors, and analysts.
Clene (Nasdaq: CLNN) announced the FDA granted an in-person Type C meeting in Q1 2026 to discuss biomarker-driven pathways for CNM-Au8. The company submitted a briefing package linking ~9–10% NfL reductions observed in HEALEY and NIH EAP studies to an 8–13% lower mortality risk across large ALS cohorts, and reported a HEALEY long-term survival benefit for CNM-Au8 30 mg (HR 0.272, 95% CI 0.096–0.772, p=0.014; 93% alive at 12 months). Exploratory IGFBP7 findings showed a 78% mortality risk reduction in responders (HR 0.22, p=0.012). Results are presented as candidate surrogate biomarker evidence and require prospective confirmation.
Clene (Nasdaq: CLNN) announced a registered direct offering of approximately $28 million on January 9, 2026, led by Boxer Capital, Coastlands Capital and Vivo Capital. An initial tranche sold 928,333 common shares with warrants at $6.50 per unit, raising about $6.03 million expected to fund operations into Q3 2026. Two additional warrant-linked tranches totaling roughly $22 million are contingent on NDA acceptance and FDA approval for CNM-Au8 in ALS. Series A and Series B warrants are exercisable immediately with tiered exercise-price increases tied to PDUFA and FDA approval announcements. BTIG is sole placement agent; closing expected on or about Jan 12, 2026.
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.
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