Lipocine reports promising interim safety for LPCN 1154 in Phase 3 PPD trial; topline Q2 2026

Lipocine Inc.

DSMB review after one-third of planned 80 participants (n=30) recommended continuation as planned without modification.
47 participants completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation.
Topline results on track for Q2 2026; second DSMB and safety update targeted early Q1 2026.
Phase 3 data expected to support 505(b)(2) NDA submission for LPCN 1154 later in 2026.
Trial conducted entirely in outpatient setting per FDA feedback; 19 U.S. clinical sites participating.

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