Welcome to our dedicated page for Lipocine news (Ticker: LPCN), a resource for investors and traders seeking the latest updates and insights on Lipocine stock.
Lipocine Inc. develops biopharmaceutical products using a proprietary technology platform for effective oral drug delivery. News about LPCN centers on clinical development of LPCN 1154, an oral brexanolone product candidate for postpartum depression, including trial progress, safety reviews and reported efficacy results.
Company updates also cover TLANDO, Lipocine’s oral testosterone replacement therapy, and related license, supply and distribution arrangements in multiple territories. Recurring financial news includes research and development spending, royalty revenue from TLANDO sales, pipeline prioritization and corporate presentations tied to the company’s oral-delivery programs.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Lipocine Inc. (NASDAQ: LPCN) announced the dosing of the first participant in a pilot clinical bridge study of LPCN 1154, an oral formulation of brexanolone aimed at treating postpartum depression (PPD). The FDA supports Lipocine's proposal to validate LPCN 1154's efficacy through a pharmacokinetic bridge to intravenous brexanolone. The pilot study, involving 12 participants, seeks to compare the safety and tolerability of LPCN 1154 with the approved injectable form. Results are anticipated in the first half of 2023, with the potential for a pivotal study and NDA filing based on these findings.
Lipocine Inc. (NASDAQ: LPCN) announced its financial results for the year ended December 31, 2022, highlighting a strategic shift towards developing neuroactive steroids for CNS disorders. The company reported a net loss of $10.8 million, or ($0.13) per diluted share, compared to a loss of $634,399, or ($0.01) per diluted share in 2021. License revenue significantly declined to $500,000 from $16.1 million in 2021. Research and development expenses rose to $8.6 million, driven by increased clinical study costs. As of December 31, 2022, the company had $32.5 million in cash, down from $46.6 million in 2021.