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 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.
Clene (NASDAQ: CLNN) reported its full year 2024 financial results and key operational updates. The company plans to submit a New Drug Application (NDA) for CNM-Au8® in ALS treatment during the second half of 2025 under the accelerated approval pathway. Key financial highlights include cash position of $12.2 million as of December 31, 2024, and a new $10.0 million debt facility secured at a lower interest rate.
The company reported a net loss of $39.4 million ($5.67 per share) for 2024, compared to $49.5 million ($9.43 per share) in 2023. Research and development expenses decreased to $20.1 million from $26.7 million, while general and administrative expenses reduced to $13.3 million from $14.4 million.
Clinical developments include plans to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025. The company is analyzing biomarker NfL data from its NIH-sponsored Early Access Protocol to support FDA requirements. Survival analysis showed a 4.1-month improvement in overall survival, with enhanced benefits observed in severe ALS patients.
Clene (NASDAQ: CLNN) has announced new evidence from a cross-regimen analysis of the HEALEY ALS Platform Trial, demonstrating significant survival benefits for ALS patients treated with CNM-Au8® 30 mg. The analysis compared Regimen C (CNM-Au8) to Regimen A, with up to 48 months follow-up.
Key findings include:
- Median survival increased by 198 days (6.5 months) in the CNM-Au8 group (951 days) versus the comparator group (753 days)
- Restricted Mean Survival Time showed a 124-day improvement
- In moderate to severe ALS patients, median survival improved by 11.9 months with a 44% decreased mortality risk
- The strongest benefits were observed in patients meeting RESTORE-ALS Trial criteria, with median survival improving by 451 days (14.8 months) and a 49% reduction in mortality risk
The company plans to launch its confirmatory Phase 3 RESTORE-ALS study in mid-2025.
Clene Inc. (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company specializing in neurodegenerative disease treatments, has announced its participation in the 37th Annual Roth Conference. The company, which focuses on developing treatments for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), will engage in a virtual fireside chat on March 18, 2025, at 9:20 am PST.
The presentation will be accessible through a webcast on the company's website's 'Events' section. Additionally, Clene's management team will be available for one-on-one investor meetings, which can be arranged through Roth representatives.
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