Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154
Tuesday, August 6, 2024 1 min read
Key Takeaway: Lipocine Inc. has completed dosing in its pivotal study for LPCN 1154, a candidate for treating postpartum depression. The study design has been aligned with the FDA, aiming for a streamlined pathway to NDA submission by 2024. Topline results are anticipated in late Q2 2024, marking a significant step for the company.
Price reaction · baseline $4.9921 (2024-08-06T15:46:00.000Z) · hit during market hours · 2 other LPCN headline(s) in the window, move may be shared
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POSITIVE FACTORS
Completion of dosing in pivotal study for LPCN 1154.
Alignment with FDA on streamlined NDA submission pathway.
Topline results expected by late Q2 2024.
Full Press Release Details
• August 6, 2024
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