Axsome reports 2Q 2026 results, Alzheimer's agitation launch, AXS-12 NDA accepted
FDA accepted the AXS-12 narcolepsy NDA with a May 1, 2027 PDUFA date as two solriamfetol ADHD trials began.
SEC filing
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Wednesday, August 19
Friday, August 14
Axsome posts ADVANCE-2 agitation results; smoking cessation trial recruiting
Monday, August 10
Tuesday, July 21
Axsome registers two Phase 3 solriamfetol trials in pediatric and adolescent ADHD
Wednesday, July 15
FDA accepts Axsome's NDA for AXS-12 in narcolepsy cataplexy
The agency set a PDUFA target action date of May 1, 2027 and does not currently plan an advisory committee meeting.
SEC filing