Clinical Trial ConcernsDespite achieving the primary endpoint, there was a high placebo response in the SYMPHONY study, which may cast doubts on AXS-12's efficacy.
CompetitionCaplyta could be positioned directly against Auvelity in the post-SSRI/post-SNRI MDD setting, introducing potential competition.
Operational IssuesA cyber-attack at Change Healthcare has made it difficult for prescriptions to get filled, potentially affecting Auvelity's sales figures.