Summary by Moomoo AI
On December 10, 2024, Clene Inc. announced that the FDA has provided a potential path for accelerated approval of CNM-Au8 in amyotrophic lateral sclerosis (ALS) through submission of additional biomarker data. The company released an updated corporate presentation on its website and presented new data from clinical trials and expanded access programs at the 35th International Symposium on ALS/MND.The new data includes long-term survival information with CNM-Au8 30 mg treatment and biomarkers of neurodegeneration, astrogliosis, and inflammation in ALS patients. This development suggests a significant step forward in Clene's ALS treatment program, potentially expediting the approval process for CNM-Au8.Clene also filed a Form 8-K with the SEC, including exhibits of the corporate presentation, research posters, and the press release announcing the FDA's guidance. The company stated it plans to use its website for future updates to the corporate presentation, indicating a shift in its investor communication strategy.