Clene Inc. - CLNN STOCK NEWS

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.

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.