Lipocine shares rise 12.67% intraday after positive interim safety data from Phase 3 PPD trial shows no major adverse events, DSMB recommends continuation.

Lipocine Inc. surged 12.67% intraday following the announcement of a positive interim safety review for its Phase 3 trial of LPCN 1154, an oral brexanolone formulation for postpartum depression. The independent Data Safety Monitoring Board confirmed no drug-related serious adverse events, dose reductions, or treatment discontinuations among 47 participants who had completed dosing. The trial, now on track for topline results in Q2 2026, demonstrated a favorable safety profile with no excessive sedation or loss of consciousness reported. The DSMB recommended proceeding without modifications, reinforcing the drug’s potential as a first-line PPD treatment with rapid relief and outpatient administration. The update, combined with the company’s emphasis on LPCN 1154’s differentiated attributes, likely drove investor optimism ahead of regulatory milestones and potential 505(b)(2) NDA submission.