Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision
Clene said it plans to submit a new drug application to the U.S. FDA at the start of the fourth quarter for CNM-Au8, its investigational ALS treatment. The company is targeting a decision around mid-2027.
Why it matters — This filing milestone for Clene's lead ALS candidate moves the company closer to potential regulatory review and a possible decision on CNM-Au8.