Lipocine To Start Testing Neuro-Steroid Candidate In Postpartum Depression Patients

The FDA has signed off Lipocine Inc's LPCN Investigational New Drug Application (IND) to initiate a Phase 2 study to evaluate LPCN 1154 for the treatment of postpartum depression (PPD) in adults.
A pharmacokinetic (PK) study to assess dose proportionality is planned to start in July 2021, with top-line results expected in the third quarter of 2021.
Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects is expected to start dosing in the fourth quarter of 2021.
Price Action: LPCN shares are up 12% at $1.49 during the market session on the last check Monday.