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) 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.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, has announced its upcoming presentation at the Emerging Growth Conference on April 17, 2025, at 12:00 p.m. EDT. The virtual presentation will include a corporate update followed by a Q&A session.
The company specializes in developing therapies for conditions including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). Their flagship investigational treatment, CNM-Au8®, is a first-in-class therapy targeting mitochondrial function and the NAD pathway while reducing oxidative stress. The presentation will be accessible through the company's website and the conference portal, with replays available afterward through the Emerging Growth Conference YouTube Channel.
Clene (NASDAQ: CLNN) has presented new evidence of remyelination and neuronal repair in Multiple Sclerosis (MS) patients treated with CNM-Au8® from the VISIONARY-MS Trial long-term extension study. The findings, presented at the AAN 2025 Annual Meeting, demonstrate significant improvements in cognition and visual function.
Key results show that over 90% of participants who experienced improvements in cognition and vision also showed corresponding improvements in MRI and visual electrophysiology tests. Specifically, 96% of LCLA responders showed improvement in MRI DTI metrics, 91% exhibited mf-VEP improvements, and 98% of SDMT responders demonstrated improvements in MRI DTI AD and/or MTR metrics.
The study validates CNM-Au8's therapeutic mechanism in supporting critical repair processes within neurons and oligodendrocytes, leading to improved neurological function and remyelination. These results are consistent with previous findings from the double-blind period of the trial.
Clene (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company specializing in neurodegenerative disease treatments including ALS and MS, has announced its participation in the upcoming Jones Healthcare and Technology Innovation Conference.
The company's management will deliver a presentation on April 9, 2025, at 11:30 am PT at the Venetian Resort in Las Vegas, NV. The event will also feature one-on-one investor meetings, which can be arranged through Jones representatives.
Interested parties can access the presentation webcast through the 'Events' section of Clene's website or via online registration.
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