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 Nanomedicine, a clinical-stage biopharmaceutical company, has received a $1 million grant from the Maryland Department of Housing and Community Development to support redeveloping its manufacturing facility in Elkton, MD. This expansion aims to boost manufacturing capacity for the anticipated commercialization of its lead drug candidate, CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). Clene expresses gratitude for the state's support and emphasizes its commitment to community infrastructure growth.
Clene Inc. (NASDAQ: CLNN) presented significant findings from its RESCUE-ALS Phase 2 trial of CNM-Au8 at the 32nd International Symposium on ALS/MND on December 10, 2021. The trial demonstrated that CNM-Au8 significantly slowed disease progression and improved quality of life in early ALS patients. Notable results included a reduced risk of major functional decline and no serious adverse effects observed. While the primary endpoint regarding motor unit index changes was not met, the therapy showed potential as a breakthrough treatment for ALS.
Clene Inc. (NASDAQ: CLNN) presented key findings from its Phase 2 RESCUE-ALS trial of CNM-Au8 at the 32nd International Symposium on ALS/MND. The trial indicated that CNM-Au8 significantly slowed disease progression in early-stage ALS patients, demonstrating reduced risk of decline in the ALSFRS-R score and improved quality of life. Notably, the treatment was well-tolerated with no serious adverse events. While the primary endpoint was not met, the results suggest potential neuroprotective effects and long-term survival benefits for patients with limb onset ALS.
Clene Inc. (NASDAQ: CLNN) has reported promising results from the RESCUE-ALS Phase 2 study of its drug candidate CNM-Au8® for amyotrophic lateral sclerosis (ALS). Data presented at the ALS ONE Research Symposium indicates that CNM-Au8 has a favorable impact on ALS progression, meeting FDA-recommended endpoints. Key findings include consistent efficacy in both limb and bulbar onset patients, with an average Combined Assessment of Function and Survival (CAFS) score improvement of +4.4 compared to a decline of -4.6 in the placebo group. Long-term survival data suggests potential benefits compared to estimated median survival rates.
Clene Inc. (NASDAQ: CLNN) announced the completion of enrollment in the HEALEY ALS Platform Trial for its leading drug candidate, CNM-Au8®, a gold nanocrystal suspension. This innovative trial is the first of its kind for ALS and aims to facilitate the development of new therapies. Topline data is expected in the second half of 2022, with plans to file a New Drug Application if CNM-Au8 meets its primary endpoint. The trial includes over 50 sites across the U.S., aiming to accelerate research and provide new hope for ALS patients.
Clene Inc. (Nasdaq: CLNN) recently shared its Q3 2021 results and updates on clinical trials. The RESCUE-ALS Phase 2 trial for CNM-Au8 indicated potential benefits for ALS patients, though it did not meet its primary endpoint. Positive exploratory data revealed clinically relevant improvements. The company also launched an FDA Expanded Access Program for ALS patients. Cash and restricted cash stood at $60.6 million. Notably, Clene reported a net income of approximately $28.9 million, influenced by an unrealized gain from contingent liabilities, contrasting with a net loss in Q3 2020.
Clene Inc. (Nasdaq: CLNN) has announced results from the RESCUE-ALS Phase 2 trial, evaluating its drug candidate CNM-Au8 for early amyotrophic lateral sclerosis (ALS). The trial did not meet its primary endpoint (MUNIX) or secondary endpoint (FVC) at week 36, although a trend indicating efficacy was observed at week 12 (p=0.057). Notably, significant improvements were noted in disease progression and quality of life measures. The trial demonstrated potential protective effects on lower motor neurons in limb onset ALS patients, comprising 70% of the ALS population. Results from the Healey ALS Platform Trial are anticipated in late 2022.
Clene Inc. (NASDAQ: CLNN) has launched a second FDA expanded access program (CNMAu8.EAP02) for its investigational therapy CNM-Au8 to assist ALS patients unable to enroll in the Healey ALS Platform Trial. This initiative aims to provide critical access to CNM-Au8, which is being investigated for treating amyotrophic lateral sclerosis, while the primary trial's results are expected in mid-2022. The program is supported by key trial sites and is part of Clene's ongoing commitment to address the needs of ALS communities.
Clene Inc. (NASDAQ: CLNN) announced significant results from its Phase 2 REPAIR-PD clinical trial for CNM-Au8, a gold nanocrystal suspension aimed at treating Parkinson's disease. The trial demonstrated a statistically significant increase in the brain NAD+/NADH ratio, a crucial marker for energy metabolism, with a p-value of 0.037. This improvement corresponds to reversing about 20 decades of normal aging. There were no serious adverse events, further reinforcing CNM-Au8's safety profile. The company presented these findings at the International Parkinson and Movement Disorder Society Virtual Congress.
Clene Inc. (NASDAQ: CLNN) announced the completion of the final patient visit in its Phase 2 RESCUE-ALS study, with close-out activities now underway. The trial involved 45 ALS patients and aimed to evaluate the efficacy and safety of CNM-Au8, a gold nanocrystal suspension. Interim results demonstrated improvements in neurophysiology endpoints, contrasting prior worsening in ALS data sets. Notably, 90% of eligible participants have chosen to continue treatment under a long-term extension of the study. Unblinded topline data are expected in Q4 2021.