Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses
Clene is preparing to submit a New Drug Application seeking accelerated approval for CNM-Au8 in amyotrophic lateral sclerosis, after completing additional biomarker analyses requested by the FDA. CEO Rob Etherington confirmed the plan in an interview.
Why it matters — A CLNN watcher would care because a planned NDA submission marks a key regulatory step for the company's lead ALS candidate, CNM-Au8.