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Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154

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.
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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

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Frequently Asked Questions

What is LPCN 1154?

LPCN 1154 is Lipocine's candidate for treating postpartum depression.

When are the topline results expected?

Topline results for LPCN 1154 are anticipated in late Q2 2024.

What is the goal for NDA submission?

The goal is to submit the NDA for LPCN 1154 in 2024.

How has Lipocine aligned with the FDA?

Lipocine has aligned its study design with the FDA for a streamlined NDA pathway.

Last updated: Aug 6, 2024