Lipocine Inc. (NASDAQ:LPCN) shares are up during Monday’s premarket session after the company’s stock plunged almost 78% on Thursday following disappointing trial data.

On Thursday, the company said LPCN 1154 did not meet its primary endpoint in a Phase 3 trial for postpartum depression (PPD).

LPCN 1154 Misses Phase 3 Endpoint

Lipocine announced that LPCN 1154 failed to show a statistically significant reduction in HAM-D17 total score compared to placebo at hour 60 in the overall study population.

Hamilton Depression Rating Scale (HAM-D) measures the severity of depression.

Post Hoc Analysis Shows Signal In Subgroup

However, in a post hoc analysis, the treatment demonstrated nominally statistically significant reductions in HAM-D scores for participants with a history of psychiatric conditions.

Based on the results of the post hoc analysis, the company applied for breakthrough therapy and fast track designations for LPCN 1154 in patients with PPD.

Company Evaluates Strategic Options

Lipocine plans to preserve capital and engage with stakeholders to evaluate all options available to the company.

Such options may include 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.

If successful, the Phase 3 trial was expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application submission in the U.S., which was expected in mid-2026.

As of March 6, 2026, the company had unrestricted cash, cash equivalents, and marketable investment securities of approximately $24.7 million.

LPCN Stock Price Activity: Lipocine shares were up 2.44% at $2.10 at last check during premarket trading on Monday, according to Benzinga Pro data.

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