Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights

Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025A second Type C meeting has been scheduled with the FDA in the third quarter of 2025 to review the survival benefit associated with CNM-Au8 dosingThe Company expects to submit a New Drug Application in the fourth quarter of 2025 for potential accelerated approval of CNM-Au8® in ALSA Type B end- ...