Lipocine

Lipocine reports that the oral brexanolone candidate LPCN 1154 missed the primary endpoint in a phase-3 study for postpartum depression, after which the stock fell by about 77%. The study of 90 patients showed no statistically significant reduction in HAM-D17 versus placebo at 60 hours. A post-hoc analysis in 54 patients with a psychiatric history, however, showed early and sustained nominally significant HAM-D reductions. LPCN 1154 was well tolerated in the overall population; Lipocine has filed for Breakthrough and Fast Track designation and is evaluating capital preservation and strategic options for further development. » Más en de.investing.com

Lipocine reports completion of the phase‑3 study of LPCN 1154: the randomized, double‑blind, placebo‑controlled trial in 90 patients showed a positive safety profile with no treatment‑related serious adverse events and no cases of excessive sedation or loss of consciousness. LPCN 1154 achieved bioequivalent systemic exposure to intravenous brexanolone and is designed as an oral, at‑home treatment. The data are intended to support a 505(b)(2) NDA submission in 2026; Lipocine had roughly $19 million in cash at the end of January, and the stock has recently risen sharply. » Más en de.investing.com

Lipocine has completed patient recruitment and dosing for the Phase‑3 study of LPCN 1154, an oral brexanolone formulation to treat postpartum depression (PPD). In the fully outpatient, randomized double‑blind study, 90 patients were enrolled; to date LPCN 1154 has shown a favorable safety profile with no study‑related discontinuations or serious drug‑related adverse events. The company expects topline safety and efficacy results in early Q2 2026 and plans to use the data for a 505(b)(2) regulatory filing in 2026. » Más en de.investing.com