Lipocine To Start Testing Neuro-Steroid Candidate In Postpartum Depression Patients
- The FDA has signed off Lipocine Inc's (NASDAQ: 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.
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