Lipocine (LPCN) announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 or oral brexanolone for the treatment of postpartum depression. In the trial, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary was not met. The company plans to complete its full analysis of the trial data in the coming weeks and plans to present the results at upcoming conferences.
Lipocine said it plans to preserve capital and engage with stakeholders, including investors, regulators, and advisors, to evaluate all options available to the company going forward. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product candidates, strategic transactions, partnerships, and other opportunities.
In pre-market trading on NasdaqCM, Lipocine shares are up 0.86 percent to $9.33.
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