Clene Inc.
CNM-Au8
amyotrophic lateral sclerosis (ALS)
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on CNM-Au8 for amyotrophic lateral sclerosis (ALS) is expected Date TBD.
Primary source
· SEC 8-K
verified 15h ago
“FDA acceptance of this NDA and issuance of a Prescription Drug User Fee Act (PDUFA) date for regulatory decision under the accelerated approval pathway could occur in the second half of 2026, with potential approval for commercial launch in”