LPCN - Lipocine soars 9% on FDA greenlight for Phase 2 LPCN 1154 study in postpartum depression

Lipocine (LPCN) jumps 9% premarket after announcing that the FDA has cleared its IND application to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ((PPD)) in adults. A pharmacokinetic ((PK)) study to assess dose proportionality is planned to start in July with top-line results expected in Q3 2021.Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to occur with the first subject dosed in Q4 2021.

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Lipocine soars 9% on FDA greenlight for Phase 2 LPCN 1154 study in postpartum depression