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Stock impact report

Lipocine Announces Financial Results for the Full Year Ended December 31, 2023 [Yahoo! Finance]

Lipocine Inc. (LPCN) 
Last lipocine inc. earnings: 11/12 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.lipocine.com
Company Research Source: Yahoo! Finance
System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone). Lipocine is developing LPCN 1154 for postpartum depression ("PPD") The bridge study results demonstrated comparative pharmacokinetics of LPCN 1154 to an approved IV infusion brexanolone The study identified a dosing regimen of LPCN 1154 to be tested in a single confirmatory pivotal PK study required for NDA filing LPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse events The Company completed a successful meeting with the U.S. Food and Drug Administration ("FDA") during which it confirmed with the FDA its proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. The use of exposure Show less Read more
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