Reports Q3 revenue $15,000, consensus $55,140. “The three potential biomarker paths that could be leveraged to increase the persuasiveness of our ALS data, as outlined by the FDA, include: the NfL analysis of our ongoing NIH-sponsored Expanded Access Program; additional ALS disease-specific biomarker changes from the HEALEY ALS Platform Trial; and NfL analysis of subjects in the open-label extension of the HEALEY ALS Platform Trial who were initially treated with placebo during the placebo-controlled portion of the trial and then received CNM-Au8 during the OLE,” said Rob Etherington, President and CEO of Clene (CLNN). “The Company anticipates completing these data analyses shortly which could support the filing of an NDA using the accelerated approval pathway.”
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