Clene Inc.
CNM-Au8
ALS
Countdown
177days
FDA decision · ~ Dec 31, 2026 estimated
What's at stake
The FDA's approval decision on CNM-Au8 for ALS is due ~ Dec 31, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“The Company intends to submit its NDA in the third quarter of 2026, which will remain a matter of FDA review.”