Lipocine disclosed that the independent Data Safety Monitoring Board completed its first review of the Phase 3 trial of LPCN 1154, an oral formulation of brexanolone for postpartum depression. The board evaluated 30 of the 80 participants who had reached the day‑seven follow‑up visit and 47 participants who had finished dosing. No treatment discontinuations, dose reductions, drug‑related serious adverse events, excessive sedation, or loss of consciousness were reported, and the board recommended that the trial continue unchanged.
The safety profile confirmed by the DSMB is a critical de‑risking step for the program. With no safety concerns identified, the company can proceed toward its planned 505(b)(2) New Drug Application submission in 2026. The review also supports the company’s strategy to bring the first oral therapy for postpartum depression to market, a condition that affects roughly 500,000 U.S. women annually and 175,000 with moderate to severe symptoms.
Financially, Lipocine posted a Q3 2025 net loss of $3.2 million, up from a $2.2 million loss in Q3 2024, and revenue of $115,000, compared with $0 in the same quarter last year. Royalty income from TLANDO sales reached $115,000, a first‑time figure for the quarter. Cash, cash equivalents, and marketable securities stood at $15.1 million, down from $21.6 million at the end of 2024, reflecting ongoing investment in the LPCN 1154 trial.
CEO Mahesh Patel highlighted the enrollment momentum and the favorable safety data, noting that the trial’s progress positions the company to deliver topline results in Q2 2026 and to file the NDA in mid‑2026. He emphasized that the safety review removes a major regulatory hurdle and strengthens the company’s competitive position against existing treatments that require inpatient administration.
Market reaction to the safety review has been positive, with analysts noting the de‑risking of the program and the potential for a first‑in‑class oral therapy to capture a large unmet market. The review’s outcome is expected to reinforce investor confidence in the company’s long‑term growth prospects, despite the current quarterly losses.
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