Brief: After Successful FDA Meeting, Clene Filing Accelerated Approval NDA For Als

Clene

04/05/2026 13:03

May 4 (Reuters) - Clene Inc CLNN.O:

AFTER SUCCESSFUL FDA MEETING, CLENE FILING ACCELERATED APPROVAL NDA FOR ALS

CLENE INC - FDA SAYS CNM-AU8 DATA MAY SUPPORT NDA UNDER ACCELERATED APPROVAL PATHWAY

CLENE INC - TO SUBMIT NDA FOR CNM-AU8 TO FDA IN Q3 2026

CLENE INC - FDA ACKNOWLEDGES NFL AS POTENTIAL SURROGATE ENDPOINT FOR ACCELERATED APPROVAL

CLENE INC - NDA SUBMISSION SUPPORTED BY PHASE 2 HEALEY ALS AND RESCUE-ALS TRIAL DATA

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