Recent Updates — LPCN

Lipocine Inc. announced that Health Canada has approved TLANDO (testosterone undecanoate) capsules for testosterone replacement therapy in adult males with hypogonadism. The approval was granted to licensing partner Verity Pharmaceuticals, which holds exclusive commercial rights to the product in North America and plans to launch it in the Canadian market by the end of 2026. TLANDO offers an oral alternative to existing injections and topical gels, featuring a fixed dosing regimen that does not require dose titration. Lipocine Inc. is a biopharmaceutical company developing oral therapeutics using its proprietary drug-delivery technology platform.

Lipocine Inc. announced the initiation of the BLOOM Phase 3 study for LPCN 1154, an oral formulation of brexanolone intended to treat postpartum depression (PPD). The placebo-controlled outpatient trial will enroll approximately 120 participants with severe PPD, with first dosing expected in early Q4 2026. This study aims to generate evidence for a potential New Drug Application under the 505(b)(2) pathway, incorporating FDA feedback and strengthened site controls following a prior Phase 3 trial that missed its primary endpoint but showed promising exploratory results. Lipocine expects average monthly cash burn of approximately $1 million during execution, supported by $23.3 million in unrestricted cash as of June 30, 2026. Lipocine is a biopharmaceutical company developing oral therapeutics using proprietary drug-delivery technology.