Lipocine Inc. announced the initiation of the BLOOM Phase 3 study for LPCN 1154, an oral formulation of brexanolone intended to treat postpartum depression (PPD). The placebo-controlled outpatient trial will enroll approximately 120 participants with severe PPD, with first dosing expected in early Q4 2026. This study aims to generate evidence for a potential New Drug Application under the 505(b)(2) pathway, incorporating FDA feedback and strengthened site controls following a prior Phase 3 trial that missed its primary endpoint but showed promising exploratory results. Lipocine expects average monthly cash burn of approximately $1 million during execution, supported by $23.3 million in unrestricted cash as of June 30, 2026. Lipocine is a biopharmaceutical company developing oral therapeutics using proprietary drug-delivery technology.
