Lipocine initiates BLOOM Phase 3 trial of LPCN 1154 oral brexanolone for postpartum depression

• Lipocine initiated the BLOOM Phase 3 trial of LPCN 1154, an oral brexanolone, as a 48-hour at-home treatment for severe postpartum depression.
• First participant dosing is expected in early Q4 2026, with about 120 participants planned.
• No new results were presented; BLOOM is designed to generate future efficacy and safety evidence for a potential 505(b)(2) NDA.
• A prior Phase 3 study missed its primary endpoint overall, though post hoc analyses excluding one site suggested symptom improvement.
• Management expects existing resources to fund the study, citing about USD 23.3 million cash as of June 30, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lipocine Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001493152-26-042466), on September 14, 2026, and is solely responsible for the information contained therein.