Lipocine Inc Stock Price, News & Analysis

Lipocine (NASDAQ: LPCN) has announced that two abstracts for their drug candidate LPCN 2101, being developed for epilepsy treatment, have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting in Atlanta, Georgia, December 5-9.

The presentations will focus on the oral toxicokinetics and clinical pharmacokinetics of LPCN 2101, a GABA A receptor modulating neuroactive steroid. The first presentation is scheduled for December 7, and the second for December 8, 2025. The abstracts are currently under embargo until November 24, 2025.

Lipocine (NASDAQ: LPCN) reported Q2 2025 financial results, highlighting a net loss of $2.2 million ($0.41 per share) and cash position of $17.9 million. The company's key developments include progress in their LPCN 1154 Phase 3 trial for postpartum depression treatment and plans to initiate a Phase 2 study for LPCN 2401 in obesity management.

Revenue for Q2 2025 included $123,000 in TLANDO royalties and $500,000 in license revenue. The company expanded TLANDO's global reach through partnerships with Aché Laboratórios for Brazil and Verity Pharma's NDS filing in Canada. Operating expenses showed improved efficiency with reduced G&A costs of $0.9 million, down from $1.5 million in Q2 2024.

Lipocine (NASDAQ: LPCN) has initiated dosing in its pivotal Phase 3 clinical trial for LPCN 1154, an oral brexanolone treatment for postpartum depression (PPD). The trial is being conducted in an outpatient setting without required medical monitoring, following FDA feedback.

The two-arm, randomized, blinded study will evaluate LPCN 1154 against placebo in women aged 15+ with severe PPD, featuring a 48-hour dosing period. The primary endpoint measures changes in the Hamilton Depression Rating Scale (HAM-D). The company expects top-line results in Q2 2026 and plans an NDA submission by mid-2026.

Lipocine Inc. (NASDAQ: LPCN) announced a virtual R&D investor event scheduled for July 9, 2025, focusing on LPCN 1154 (BRLIZIO™) for postpartum depression (PPD) treatment. The event will feature Dr. Kristina M. Deligiannidis from Zucker Hillside Hospital and company management discussing PPD treatment landscape and unmet needs. LPCN 1154, a bioidentical neuroactive steroid, is being developed as a potential first-line treatment for PPD with rapid symptom relief. The drug aims to provide a 48-hour treatment duration through oral administration in an outpatient setting. The event will include updates on clinical programs, regulatory status, and development progress, including details on an ongoing Phase 3 registrational study with expected results in Q2-2026.

Lipocine (NASDAQ: LPCN) announced that its licensing partner Verity Pharma has filed a New Drug Submission (NDS) for TLANDO in Canada. TLANDO is the first FDA-approved oral testosterone replacement therapy (TRT) that doesn't require dose titration. The Canadian market presents a significant opportunity with over 700,000 annual TRT prescriptions, with approximately 50% of patients covered by private insurance. The limited promotional activities for existing TRTs in Canada could provide TLANDO an opportunity to capture substantial market share. This submission follows a January 2024 exclusive licensing agreement between Lipocine and Verity Pharma for TLANDO's commercial rights in the US and Canada.

Lipocine's (NASDAQ: LPCN) development candidate LPCN 1148 for treating men with cirrhosis has been featured in the June 2025 edition of Hepatology's "Highlights" section. The article discusses Phase 2 trial results for this "First in Class" product candidate, which targets overt hepatic encephalopathy and sarcopenia indications. The trial involved a 24-week randomized study comparing oral LPCN 1148 to placebo.

The FDA has granted fast track designation to LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis. The company is currently seeking partnership opportunities for LPCN 1148. The treatment represents a novel approach, as current sarcopenia treatment in cirrhosis is limited to diet and exercise.

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.