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Lipocine Completes Phase 3 Enrollment for Postpartum Depression Drug

Story Highlights
  • Lipocine completed enrollment and dosing of 90 patients in a Phase 3 trial of LPCN 1154 for postpartum depression, reporting a favorable safety profile.
  • The outpatient Phase 3 study of oral brexanolone is designed to support a 2026 NDA filing, potentially positioning LPCN 1154 as a rapid, at-home first-line therapy for severe postpartum depression amid significant unmet need.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Lipocine Completes Phase 3 Enrollment for Postpartum Depression Drug

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Lipocine ( (LPCN) ) has shared an announcement.

On January 20, 2026, Lipocine announced it has completed enrollment and dosing of 90 patients in its Phase 3 clinical trial of LPCN 1154, an oral formulation of brexanolone, for the treatment of postpartum depression, with the candidate showing a favorable safety profile to date and no drug-related serious adverse events or treatment discontinuations. The pivotal, randomized, double-blind outpatient study in women with severe postpartum depression is intended to support a planned 505(b)(2) NDA submission in 2026, positioning LPCN 1154 as a potential first-line, at-home, rapid-acting treatment option in an area where current therapies have slow onset and tolerability limitations, and underscoring Lipocine’s strategic focus on high-need neuropsychiatric indications.

The most recent analyst rating on (LPCN) stock is a Buy with a $12.50 price target. To see the full list of analyst forecasts on Lipocine stock, see the LPCN Stock Forecast page.

Spark’s Take on LPCN Stock

According to Spark, TipRanks’ AI Analyst, LPCN is a Neutral.

Overall score is pulled down primarily by weak earnings quality and persistent cash burn despite a debt-free balance sheet. Technicals are strong but extremely overbought, adding near-term risk. Positive Phase 3 trial progress and safety updates provide a meaningful upside catalyst, but valuation remains challenged given ongoing losses.

To see Spark’s full report on LPCN stock, click here.

More about Lipocine

Lipocine Inc. is a biopharmaceutical company that leverages a proprietary oral drug delivery technology platform to develop innovative, patient-friendly therapies targeting large markets with significant unmet medical needs. Its pipeline includes candidates for postpartum depression, major depressive disorder, treatment-resistant depression, epilepsy, essential tremor, obesity management, liver cirrhosis symptoms, and prevention of preterm birth, alongside TLANDO, an FDA-approved oral testosterone prodrug for hypogonadism in adult males.

Average Trading Volume: 111,312

Technical Sentiment Signal: Buy

Current Market Cap: $61.79M

See more data about LPCN stock on TipRanks’ Stock Analysis page.

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