Lipocine (LPCN) announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154, its investigational oral treatment for postpartum depression. Results are expected in Q2 2026. Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider. The company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.
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