Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC 0- ∞ Ctrough criterion was met LPCN 1154 was well tolerated with no sedation or somnolence events observed On track for NDA filing, targeted by end of Q4 2024 SALT LAKE CITY , June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutic...
SALT LAKE CITY , June 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia a...
SALT LAKE CITY , May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1...
SALT LAKE CITY , May 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy. Presentation Details Title Intervention with oral LPC...
Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024 Topline results anticipated late in 2Q 2024 SALT LAKE CITY , May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPC...
LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GI...
Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates a...
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