Lipocine shares surge 11.67% intraday after positive interim safety review of Phase 3 PPD trial.

Lipocine Inc. surged 11.67% intraday following the announcement of a positive interim safety review for its Phase 3 trial of LPCN 1154, an oral brexanolone treatment for postpartum depression (PPD). The Data Safety Monitoring Board (DSMB) confirmed no serious adverse events, dose reductions, or excessive sedation in 47 of 80 enrolled participants, allowing the trial to proceed without modification. The results, highlighted in multiple global press releases, underscore the drug’s favorable safety profile and potential to address unmet needs in PPD treatment. The trial’s outpatient design and expected 2026 top-line data, coupled with plans for a 505(b)(2) NDA submission, fueled investor optimism. The stock’s sharp intraday gain aligns with the positive clinical update, emphasizing progress toward a potential market approval for a novel, rapidly acting oral therapy in a high-unmet-need therapeutic area.