Lipocine's PPD Phase 3 study hits 80% enrollment; DSMB review in Jan 2026

Lipocine Inc.

66 of 80 planned participants randomized in Phase 3 trial of LPCN 1154 for postpartum depression.
Second independent DSMB review planned for mid-January 2026; first review recommended continuation.
Topline results expected Q2 2026; NDA submission under 505(b)(2) planned for 2026.
Study conducted entirely outpatient; no medical monitoring required per FDA feedback.

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