Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on oral drug delivery technology, has announced its participation in A.G.P.'s Annual Healthcare Company Showcase. The virtual presentation is scheduled for Wednesday, May 21, 2025, at 4:00 pm ET. Investors can access the presentation and its replay through the company's website's Investors section. The company's presentation will highlight its proprietary technology platform designed to enhance therapeutics through effective oral delivery solutions.

Lipocine Inc. (NASDAQ: LPCN) reported Q1 2025 financial results and provided corporate updates. The company ended Q1 with $19.7 million in cash and equivalents, down from $21.6M in Q4 2024. Lipocine posted a net loss of $1.9 million ($0.35/share) compared to net income of $3.5M ($0.66/share) in Q1 2024. Key developments include: initiating Phase 3 study of LPCN 1154 for postpartum depression with first patient dosing expected in Q2 2025; advancing LPCN 2401 for obesity management as an adjunct to GLP-1 therapies; and expanding TLANDO partnerships with Aché for Brazilian market rights. Revenue declined with $94,000 in TLANDO royalties vs. $117,000 in Q1 2024, while R&D expenses decreased to $1.1M from $2.8M, and G&A expenses dropped to $1.1M from $1.6M year-over-year.

Lipocine Inc. (NASDAQ: LPCN) has secured a license and supply agreement with Aché Laboratórios Farmacêuitcos for TLANDO® in Brazil. The agreement grants Aché exclusive marketing rights in Brazil, where the prescription testosterone market has shown impressive growth with a 34% CAGR from 2019 to 2023. Notably, Brazil currently has no registered oral testosterone therapy.

The deal includes an upfront payment to Lipocine, with potential additional regulatory milestone payments and royalties on net sales. Aché will handle regulatory submission and approval processes in Brazil. This partnership leverages Aché's established commercial presence and regulatory expertise in the Brazilian pharmaceutical market.

Lipocine (NASDAQ: LPCN) has initiated a Phase 3 trial for LPCN 1154 (oral brexanolone) for treating postpartum depression (PPD). The registration-enabling trial follows successful pharmacokinetic bridge study results showing comparable exposure between LPCN 1154 and the reference drug.

The trial design features a two-arm, randomized, blinded study comparing LPCN 1154 to placebo in women aged 15 and older with severe PPD. Key aspects include:

• 48-hour at-home self-administration dosing period
• First patient dosing expected in Q2/2025
• Primary endpoint: Change from baseline in Hamilton Depression Rating Scale (HAM-D)
• Secondary endpoints: Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A)

The trial aims to support a global registration package for LPCN 1154, potentially positioning it as a first-line option for rapid PPD symptom relief.

Lipocine (NASDAQ: LPCN) reported financial results for 2024, showing a net income of $8,400 compared to a $16.4M loss in 2023. Revenue reached $11.2M, primarily from license agreements with Verity Pharma, SPC Korea, and Pharmalink for TLANDO commercialization.

Key developments include: FDA requiring additional safety and efficacy study for LPCN 1154 (oral brexanolone) for postpartum depression treatment, with Phase 3 study initiation expected in Q2 2025; positive qEEG study data for oral brexanolone; and Fast Track designation for LPCN 1148 for sarcopenia in decompensated cirrhosis patients.

The company maintained strong liquidity with $21.6M in cash and equivalents as of December 31, 2024. R&D expenses decreased to $7.4M from $10.2M in 2023, while G&A expenses remained stable at $5.0M.

Lipocine Inc (NASDAQ: LPCN) announced significant FDA labeling changes for testosterone products following the TRAVERSE clinical trial and post-market blood pressure studies. The FDA has removed the Boxed Warning related to cardiovascular risks from testosterone product labels, while maintaining 'Limitation of Use' language for age-related hypogonadism.

The updated labels will include TRAVERSE trial results and product-specific information on blood pressure effects. These changes are expected to benefit Lipocine's approved testosterone replacement therapy and its development pipeline, which includes candidates for obesity management (LPCN 2401), liver cirrhosis (LPCN 1148), and metabolic dysfunction-associated steatohepatitis (LPCN 1144).

The company has an exclusive license agreement with Verity Pharma since 2024 for marketing rights in the United States and Canada, pending approval.

Lipocine (NASDAQ: LPCN) has received updated FDA guidance for LPCN 1154, its postpartum depression (PPD) treatment candidate. The FDA has indicated that beyond the previously completed PK bridge data, an additional efficacy and safety study in the target population will be required for 505(b)(2) NDA submission.

Following comparable exposure results between LPCN 1154 and the reference drug in the completed PK bridge study, Lipocine is planning to proceed with a phase 3 safety and efficacy study. The company views this requirement as an opportunity to generate valuable safety and depression symptom relief data for product labeling and potential clinical investigation exclusivity for a 48-hour, oral treatment option. Additionally, the planned study will explore oral brexanolone's potential in treating anxiety disorders.

Lipocine (NASDAQ: LPCN) has received Fast Track Designation from the FDA for LPCN 1148, targeting sarcopenia treatment in patients with decompensated cirrhosis. The designation follows positive results from a Phase 2 proof-of-concept study where LPCN 1148, an oral prodrug of bioidentical testosterone, demonstrated improvements in sarcopenia and associated clinical outcomes.

LPCN 1148 aims to be a 'First in Class' treatment where no current therapy exists. The Fast Track status enables benefits including more frequent FDA meetings, enhanced communication about clinical trial design, eligibility for Accelerated Approval and Priority Review, and Rolling Review submission options for the New Drug Application (NDA).

Lipocine announced the publication of LPCN 1148's Phase 2 clinical trial results in Hepatology journal and its discussion at The Liver Meeting 2024. The study evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. At 24 weeks, LPCN 1148 showed significant improvement in sarcopenia compared to placebo and resulted in fewer episodes of overt hepatic encephalopathy (OHE), despite patients being on background therapies. The treatment also demonstrated beneficial effects on muscle quality, hemoglobin, and patient-reported symptoms. LPCN 1148 is positioned as a potential 'First in Class' product for OHE and sarcopenia indications.