Welcome to our dedicated page for Lipocine news (Ticker: LPCN), a resource for investors and traders seeking the latest updates and insights on Lipocine stock.
Lipocine Inc. (NASDAQ: LPCN) is a biopharmaceutical company that publicly describes itself as leveraging a proprietary technology platform to develop therapeutics with effective oral delivery. News about Lipocine often centers on clinical trial milestones, regulatory interactions, and partnering activity related to its oral drug candidates.
A key focus of recent news is LPCN 1154, an oral formulation of brexanolone in development for the potential treatment of postpartum depression (PPD). Company press releases highlight the initiation of a pivotal Phase 3 trial, first patient dosing, enrollment progress, interim safety reviews by an independent Data Safety Monitoring Board, and plans to use Phase 3 data to support a 505(b)(2) NDA submission. Updates also describe the outpatient design of the trial and its target population of women with severe PPD.
News flow also covers LPCN 2401, an oral proprietary anabolic androgen receptor agonist being evaluated in obesity‑related settings. Lipocine has reported Phase 2 clinical data showing changes in body composition and liver‑related measures in men with obesity and metabolic dysfunction associated steatohepatitis, and has presented these data at the ObesityWeek meeting. Additional releases discuss regulatory status and development plans for proof‑of‑concept studies.
Other recurring topics include LPCN 2101 for the potential treatment of epilepsy, with announcements about abstract acceptances and poster presentations at the American Epilepsy Society annual meeting, as well as corporate updates on financial results, TLANDO licensing and royalty revenue, and participation in investor conferences. Investors and observers can use the LPCN news stream to follow clinical progress, safety updates, licensing developments, and strategic communications that the company files or references in its SEC reports.
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) 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).
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