Reports 2023 revenue $654,000, consensus $560,000. “In 2024 we will continue to advance our regulatory discussions with the U.S. Food and Drug Administration that we anticipate will include new data on biomarkers, as well as additional clinical function and survival data in people living with ALS,” said Rob Etherington, President and CEO of Clene. “Having held our initial discussion with the FDA in the fourth quarter of last year, we have a clear understanding of the additional data required to support an accelerated approval pathway filing for CNM-Au8. We believe that we can provide additional supportive evidence to advance discussions with the FDA with the potential to file an NDA later this year.”
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Read More on CLNN:
- Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights
- Clene Announces Breakthrough CNM-Au8 Treatment Results
- Clene presents clinical results of CNM-Au8 30mg treatment
- Clene Presents Clinical Results of CNM-Au8® 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024
- Clene’s CNM-Au8 Shows Promise in ALS Survival Rates
