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 Inc. (NASDAQ: CLNN) has announced promising new data from the open-label extension of its RESCUE-ALS study, revealing a significant 70% survival benefit for ALS patients treated with CNM-Au8®. The interim analysis showed a hazard ratio of 0.3 (p=0.006), indicating a lower mortality risk compared to the ENCALS prediction model. The Phase 2 study also highlighted benefits in slowing disease progression and enhancing life quality. CEO Rob Etherington expresses optimism for future trials and the potential to change treatment paradigms for ALS.
Clene Inc. (NASDAQ: CLNN) reported promising interim results from the RESCUE-ALS trial at the 2022 MDA Clinical & Scientific Conference. The trial indicated a 70% decreased risk of death for participants who entered the long-term open-label extension compared to predictions from the ENCALS risk model. The CNM-Au8 treatment showed significant benefits in slowing ALS disease progression, with improvements in quality of life metrics. Clene aims to validate these findings during ongoing larger clinical studies.
Clene Inc. (Nasdaq: CLNN) reported a full year 2021 net loss of $9.7 million, or $0.16 per share, improving from a loss of $19.3 million, or $1.10 per share, in 2020. As of December 31, 2021, cash and restricted cash totaled $50.3 million. Clene anticipates funding will last into Q2 2023. Key clinical milestones in 2022 include data from the HEALEY ALS Platform Trial and the VISIONARY-MS Trial, with results expected in the second half of 2022. The company also received two European patents regarding its nanotherapeutic drugs and a $1 million grant for a new manufacturing facility.
Clene Inc. (NASDAQ: CLNN), a biopharmaceutical company focused on treating neurodegenerative diseases, announced its participation in several upcoming healthcare conferences. Key events include the Roth 34th Annual Healthcare Conference on March 14, 2022, and the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, with respective presentation times of 3:00 PM ET and 8:40 AM ET. Webcasts will be available for on-demand viewing on the company's website. Clene aims to revolutionize treatments targeting energetic failure in neurological diseases.
Clene Inc. (NASDAQ: CLNN) announced promising interim data from its VISIONARY-MS Phase 2 trial and positive results from the REPAIR-MS trial, showcasing its lead drug candidate, CNM-Au8®, for treating Multiple Sclerosis (MS). The VISIONARY-MS trial shows significant improvements in the modified MS Functional Composite scores after 48 weeks of treatment, indicating potential neurological benefits. The REPAIR-MS trial demonstrated a notable increase in brain energy metabolism, with a 14.3% improvement in NAD+/NADH ratios. Clene aims to share unblinded data by late 2022.
Clene Inc. (NASDAQ: CLNN) announced it will present updated blinded data from its VISIONARY-MS study and results from the REPAIR-MS trial for stable relapsing MS at the ACTRIMS Forum 2022, held from Feb. 24-26 in West Palm Beach, FL. The presentations will include insights on CNM-Au8, a treatment targeting chronic optic neuropathy, and improvements in brain energy metabolism for MS patients. Both posters will be available on demand at the conference portal and on Clene's website starting Feb. 24, 2022.
Clene Inc. (NASDAQ: CLNN) announced key updates regarding its clinical programs, particularly for its lead candidate CNM-Au8 for treating neurodegenerative diseases. The HEALEY ALS Platform Trial has completed enrollment, with top-line data expected in the second half of 2022. Promising survival benefits from the RESCUE-ALS trial will be presented at a conference in March 2022. Meanwhile, the VISIONARY-MS trial is concluding early due to COVID-19 challenges, with unblinded data expected in the same timeframe. Clene is also moving forward with its COVID-19 trial in Brazil.
Clene Inc. (NASDAQ: CLNN) has appointed Morgan Brown as Chief Financial Officer effective February 1, 2022. Brown is a seasoned healthcare executive with extensive experience in financial leadership, particularly in the biopharmaceutical sector. He has previously raised over $1 billion in equity and debt financing and managed significant out-licensing transactions. His leadership comes during a critical phase in Clene's growth as they approach the potential commercialization of their lead drug candidate, CNM-Au8, in ALS.
Clene Inc. (NASDAQ: CLNN) has enrolled over 50% of participants in its Phase 2 study evaluating CNM-ZnAg, a zinc-silver ionic solution, for treating COVID-19 in Brazil. The study, with 276 planned participants, aims to determine the drug's efficacy in preventing hospitalization and achieving symptom resolution. Topline results are anticipated in 1H 2022. Clene's President emphasized the need for new therapeutic options due to ongoing virus mutations, highlighting CNM-ZnAg's potential if proven effective.
Clene Inc. (NASDAQ: CLNN) announced the validation of key patents from the European Patent Office that protect its innovative processes for treating neurodegenerative diseases. The patents enhance the company's lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at treating amyotrophic lateral sclerosis (ALS). This significant development supports a Phase 3 registration study expected to reveal topline results in H2 2022. The patents offer extensive coverage for Clene's manufacturing methods and treatment approaches, bolstering its position in major global healthcare markets.