Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision
Clene Inc (CLNN) plans to submit an FDA application for its ALS drug CNM-Au8 in Q4, aiming for a mid-2027 decision. CEO Etherington cited survival benefits and neurofilament light changes as supporting data. The company has held five FDA meetings and completed financing to support the filing. If approved, CNM-Au8 could address thousands of patients annually, with Clene working on insurer and payer agreements.


