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
day 0 close · peak
+2.6%
Market Sentiment Analysis
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.
BiopharmaWatch Analysis
From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+266%
120-day peak, hindsight
Typical move
50.5%
average across 4 past catalysts
Cash runway
~22 mo
Low dilution risk
Lead asset
testosterone undecanoate, LPCN 1021
Phase 3 · Male Hypogonadism
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