Lipocine Achieves 80% Enrollment Completion in LPCN 1154 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
0mins
Lipocine announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154, or oral brexanolone, for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026. Following the first DSMB review, the board recommended that the trial continue as planned without modification. The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the FDA, the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider. Data from this Phase 3 trial are expected to support a 505(b) NDA submission for LPCN 1154 in 2026.
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Analyst Views on LPCN
Wall Street analysts forecast LPCN stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for LPCN is 6.88 USD with a low forecast of 6.75 USD and a high forecast of 7.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 10.380
Low
6.75
Averages
6.88
High
7.00
Current: 10.380
Low
6.75
Averages
6.88
High
7.00
About LPCN
Lipocine Inc. is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. The Company’s clinical development candidates include: LPCN 1154, oral brexanolone, for the treatment of postpartum depression, LPCN 2101, for the treatment of epilepsy, LPCN 2203, an oral candidate targeted for the management of essential tremor, LPCN 2401, an oral proprietary anabolic androgen receptor agonist for improved body composition in obesity management, and LPCN 1148, for the management of decompensated cirrhosis. It is also developing LPCN 1107, for the prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, and LPCN 1144, for the treatment of metabolic dysfunction-associated steatohepatitis. Its product candidate, TLANDO, is a novel oral prodrug of testosterone containing testosterone undecanoate developed by the Company.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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