Lipocine: Phase 3 PPD trial passes second DSMB safety review; topline data due Q2 2026

Lipocine Inc.

DSMB reviewed safety data from 82 randomized patients; recommended trial continue without modification.
No drug discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs reported.
Study no longer screening new participants; still enrolling eligible patients.
Topline safety and efficacy results expected early Q2 2026; data to support NDA submission.
CEO cites confidence in safety profile; potential for new treatment paradigm.

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