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 Inc. (Nasdaq: CLNN) announced positive results from the open-label extension (OLE) of its Phase 2 RESCUE-ALS trial for its treatment CNM-Au8® in patients with early amyotrophic lateral sclerosis (ALS). Key findings include a significant preservation of function measured by the ALSFRS-R with a p-value of 0.0159 over 48 weeks, and an overall 52% reduction in the risk of ALS clinical worsening across 120 weeks (HR: 0.478, p=0.0494). The treatment was well-tolerated without long-term safety concerns. These results suggest that early treatment with CNM-Au8 may improve patient functionality and slow disease progression in ALS.
Clene Inc. (Nasdaq: CLNN) reported updated results from the VISIONARY-MS Phase 2 trial at the ACTRIMS Forum 2023, demonstrating positive clinical outcomes for CNM-Au8 in treating stable relapsing MS patients. Key findings include:
- Visual Evoked Potential (VEP) results showed improved signaling from the eye to the brain.
- MRI analysis indicated significant improvements in brain structure integrity.
- CNM-Au8 treatment was well-tolerated with no major safety concerns.
These results support further investigation into CNM-Au8, addressing the significant unmet needs in MS therapeutics.
Clene Inc. (Nasdaq: CLNN) announced promising results from the VISIONARY-MS trial investigating CNM-Au8 in stable relapsing multiple sclerosis (MS) patients. Updated MRI results showed significant improvements in brain neuronal structural integrity and myelin health, independent of immunomodulatory effects. Among the 68 participants with advanced MRI data, key metrics indicated robust enhancements in white matter integrity. These findings support previous clinical results demonstrating global neurological function improvements. Clene plans to initiate a Phase 3 study to further explore CNM-Au8's potential in addressing unmet needs in MS treatment.
Clene Inc. (Nasdaq: CLNN) will participate in Renmark Financial Communications’ Virtual Non-Deal Roadshow Series on January 18 and 23, 2023. The company invites investors and stakeholders to attend these free live events, featuring presentations from CEO Rob Etherington and CFO Morgan Brown, followed by a Q&A session. Registration is recommended as attendance may be limited, but replays will be available on the company's Investor website afterward. Clene focuses on developing treatments for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced that its Phase 2 trial of CNM-ZnAg, designed for treating non-hospitalized COVID-19 patients, did not meet its primary endpoint of substantial symptom resolution. Conducted in Brazil, the trial involved 288 participants and compared low and high doses of CNM-ZnAg to a placebo. Although the treatment showed a positive safety profile, with no adverse effects noted, the company decided to cease further development for COVID-19. Clene will refocus on its lead asset, CNM-Au8, for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) has secured a $5 million debt facility from the Maryland Department of Housing and Community Development. This loan, sourced through the State Small Business Credit Initiative, carries a 6% interest rate, maturing in 60 months. The funding will support Clene's efforts to advance CMN-Au8, a treatment for neurodegenerative diseases like ALS, while promoting pharmaceutical manufacturing jobs in Maryland. Clene's management highlights the loan as a successful public-private partnership aimed at creating value in the biopharmaceutical sector.
Clene Inc. (Nasdaq: CLNN) presented positive results from the VISIONARY-MS trial at the 14th Annual PACTRIMS Congress. The trial evaluated CNM-Au8 in stable multiple sclerosis (MS) patients. Key findings showed significant improvements in low contrast vision and global neurological function, as measured by the mMSFC, compared to placebo. Notably, CNM-Au8 was well-tolerated with no significant safety issues. Despite the trial being prematurely stopped due to COVID-19, these results may address an unmet need in MS treatment, prompting plans for a Phase 3 study.
Clene Inc. (CLNN) reported promising outcomes for its CNM-Au8® in the Healey ALS Platform Trial, showcasing a >90% reduction in mortality risk at 24 weeks. The Phase 2 VISIONARY-MS trial also reported positive results, meeting both primary and secondary endpoints regarding neurological improvement. As of September 30, 2022, Clene had cash and equivalents of $16.2 million, following a $10.8 million stock offering. However, the company posted a net loss of $11.0 million in Q3 2022, down from a net income of $28.9 million the previous year, influenced by contingent earn-out liabilities.
Clene Inc. (CLNN) announced a registered direct offering of 10,723,926 shares at $1.01 each, expected to close around November 2, 2022, raising approximately $10.8 million. The funds will support general corporate purposes and the clinical development of CNM-Au8. Additionally, Clene secured a $5 million Loan Facility from the Maryland DHCD, contingent on matching this with $5 million in new equity capital, which the offering will fulfill. These financings aim to strengthen Clene's balance sheet and advance therapies for ALS and other neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced topline results from the Healey ALS Platform trial, revealing that while the primary endpoint was not met, the 30 mg dose of CNM-Au8 showed a greater than 90% reduction in the risk of death at 24 weeks. The study failed to meet secondary endpoints of function and respiratory capacity, but survival results were consistent with earlier Phase 2 trials. Clene plans to continue the open-label extension of CNM-Au8 and is discussing an Expanded Access Protocol for eligible participants.
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