SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). The randomized, double-blind, placebo-controlled study enrolled a total of 90 pa ...

Core Viewpoint - Lipocine Inc. has completed enrollment and dosing in its Phase 3 clinical trial for LPCN 1154, an oral formulation of brexanolone aimed at treating postpartum depression (PPD) [1][2]. Group 1: Clinical Trial Details - The Phase 3 study involved 90 patients randomized to receive either LPCN 1154 or a placebo, demonstrating a favorable safety profile with no serious adverse events reported [2][3]. - The trial is designed as a pivotal, randomized, double-blind study for women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting [3]. - Topline safety and efficacy results are expected to be reported in early Q2 2026, which will support a 505(b)(2) NDA submission for LPCN 1154 [2][3]. Group 2: Product Information - LPCN 1154 is being developed as a convenient at-home treatment for rapid relief of postpartum depression, potentially serving as a first-line treatment option for women with PPD [4]. - The product is particularly beneficial for patients with severe PPD, including those at elevated suicide risk, where rapid improvement is critical [4]. Group 3: Market Context and Unmet Needs - Postpartum depression is a significant mental health issue affecting 20-40% of obstetric patients, with current treatment options limited by delayed onset and tolerability concerns [5]. - Traditional antidepressants, not specifically approved for PPD, have slow onset and side effects, highlighting the need for effective treatments like LPCN 1154 [5]. Group 4: Company Overview - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [6]. - The company's development pipeline includes various candidates for mental health and other conditions, with LPCN 1154 being a key focus for postpartum depression [7].

Core Viewpoint - Lipocine Inc. has completed a scheduled independent Data Safety Monitoring Board (DSMB) review of its Phase 3 clinical trial for LPCN 1154, which is aimed at treating postpartum depression (PPD), and the trial will continue without modifications [1][2]. Group 1: Clinical Trial Details - The DSMB's recommendation was based on safety data from 82 randomized participants, with 74 completing dosing, and no serious adverse events or treatment discontinuations reported [2][7]. - The study is no longer screening new participants but continues to enroll eligible participants, with topline safety and efficacy results expected in early Q2 2026 [3][4]. - The Phase 3 study is a pivotal, randomized, double-blind trial comparing LPCN 1154 to placebo in women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting [4][5]. Group 2: Product Overview - LPCN 1154 is an oral formulation of brexanolone designed for rapid relief of PPD, potentially becoming a first-line treatment option for women, with no significant risk of adverse reactions to breastfed infants [5][6]. - The product aims to address the unmet medical needs in PPD treatment, as traditional antidepressants have slow onset and side effects [6]. Group 3: Company Background - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [8][9]. - The company's development pipeline includes several candidates for various conditions, including LPCN 2201 for major depressive disorder and LPCN 2101 for epilepsy, among others [9].

Core Viewpoint - Biogen Inc. announced a positive opinion from the CHMP recommending marketing authorization for ZURZUVAE (zuranolone) for treating postpartum depression (PPD) in adults, which could be the first EU-approved treatment specifically for PPD if approved by the European Commission [1][5]. Company Summary - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create shareholder value [8]. - The company collaborates with Sage Therapeutics for the development and commercialization of ZURZUVAE, holding exclusive rights outside the U.S. [7]. Product Summary - ZURZUVAE is a once-daily, oral, 14-day treatment for PPD, approved by the FDA in 2023, and is a neuroactive steroid that modulates GABA-A receptors [6]. - The treatment has shown potential for symptom improvement as early as day three of a 14-day course, with significant reductions in depressive symptoms observed [2][4]. Market Opportunity - An estimated 5-20% of women experience PPD symptoms in Europe, with many cases going undiagnosed due to varying clinical guidelines [3]. - The recommendation for ZURZUVAE is based on the SKYLARK Study, which demonstrated significant efficacy in reducing depression severity compared to placebo [4].

Core Insights - Lipocine Inc. is hosting a virtual R&D investor event on July 9, 2025, focusing on postpartum depression (PPD) and featuring Dr. Kristina M. Deligiannidis [1][4] - LPCN 1154 (BRLIZIO™) is being developed as a potential first-line treatment for rapid symptom relief in women with PPD, with a 48-hour treatment duration in an outpatient setting [3][9] - The event will provide updates on clinical, regulatory, and development aspects, including a Phase 3 registrational study expected to read out in Q2-2026 [4] Company Overview - Lipocine is a biopharmaceutical company that utilizes a proprietary technology platform for effective oral delivery of therapeutics, targeting large markets with significant unmet medical needs [12] - The company has multiple drug candidates in development, including LPCN 2101 for epilepsy and LPCN 2203 for essential tremor, alongside LPCN 1154 for PPD [13] Postpartum Depression Insights - PPD is a serious mood disorder that can have adverse effects on maternal and infant health, with symptoms persisting up to 12 months after childbirth [2][10] - A survey indicated that obstetricians believe 20-40% of their patients may suffer from PPD, with 64% of affected women reporting comorbid anxiety symptoms [11]

Summary of Lipocene's Conference Call Company Overview - **Company Name**: Lipocene - **Ticker**: LPCN - **Market Cap**: Approximately $20 million - **Focus**: Biopharmaceutical company developing treatments for postpartum depression and obesity management [1][2] Core Products and Pipeline LPCN 1150 (Postpartum Depression Treatment) - **Mechanism**: Brexanolone (allopregnanolone), a bioidentical hormone that stabilizes mood, is a GABA positive allosteric modulator [24][25] - **Market Potential**: Approximately 250,000 mothers suffer from postpartum depression, with 60,000 to 80,000 seeking intervention [30][31] - **Clinical Development**: - Phase III study initiated, outpatient design, 48-hour treatment duration, targeting 80 patients [25][27] - Expected ANDA filing in about a year, with low clinical risk due to established efficacy of the molecule [26][27] - **Market Share Potential**: Estimated 30% to 50% market share, with market size projected between $500 million to $1 billion in the US [31][32] LPCN 2401 (Obesity Management) - **Target Population**: GLP-1 users, with nearly 30 million Americans expected to use GLP-1s [5][6] - **Mechanism**: A bioidentical myostatin inhibitor that works on fat, muscle, and bone, showing positive Phase II results [7][12] - **Clinical Development**: - Upcoming Phase II proof of concept study as an adjunct to GLP-1, with first patient dosing expected in Q3 of the current year [13][18] - Focus on weight loss and fat loss, with a goal to maintain or improve GLP-1 related weight loss [9][10] - **Market Opportunity**: Addresses unmet needs in quality weight loss and fat loss, particularly for patients concerned about weight rebound after stopping GLP-1 [12][15] Financial Overview - **Cash Management**: - Current spending is approximately $3 million per quarter, with cash runway expected for at least 12 months [33] - Focused and frugal spending strategy to support ongoing studies [33] Key Takeaways - **Investor Interest**: Both LPCN 1150 and LPCN 2401 are seen as valuable assets, with significant market potential in their respective fields [4][5] - **Regulatory Perspective**: Positive regulatory feedback for LPCN 1150, allowing for outpatient studies, which is favorable for product labeling [27] - **Partnership Opportunities**: The company is open to partnerships for LPCN 2401 post-proof of concept [19][20] Additional Insights - **Market Trends**: Increasing diagnosis rates for postpartum depression and obesity management create a favorable environment for Lipocene's products [31][21] - **Clinical Efficacy**: Previous studies indicate strong efficacy for both LPCN 1150 and LPCN 2401, with a focus on quality weight loss and maintaining lean mass [15][16][17]