Lipocine initiates BLOOM Phase 3 of LPCN 1154 for postpartum depression

Lipocine Inc.

BLOOM to enroll ~120 patients with severe PPD; first dosing expected early Q4 2026.
Prior Phase 3 missed primary endpoint; post hoc analysis excluded one site with ~40% undetectable drug.
No treatment-related severe/serious AEs or excessive sedation in prior Phase 3.
Company has $23.3M cash (6/30/26); expects ~$1M/month cash use during study.
Study incorporates FDA feedback and strengthened site quality controls.

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