LPCN

SALT LAKE CITY, May 7, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2026 and provided a corporate update. Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression ("PPD") In April 2026, Lipocine announced topline results from its Phase 3 placebo-controlled trial (N=90) evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D (Hamilton Depression Rating Scale) total score compared to placebo at hour 60 in the full analysis set and the primary endpoint was not met. The Phase 3 results showed LPCN 1154 to be well tolerated, demonstrating a differentiated safety profile supportive of outpatient, at-home use, with no treatment-related serious adverse events, no cases of excessive sedation or loss of consciousness, and no treatment-related discontinuations. In a post hoc analysis of participants with a history of psychiatric conditions (n=54), LPCN 1154 showed statistically significant and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30. Based on these findings, Lipocine has applied for breakthrough therapy and fast track designations for LPCN 1154 in PPD and is awaiting FDA feedback. The Company intends to complete its full analysis of the Phase 3 trial data and plans to present results at upcoming medical conferences. For more information on the Phase 3 trial, refer to clinicaltrials.gov: NCT06979544. The Company is evaluating all options regarding the potential path forward for LPCN 1154. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol in patients with a history of psychiatric conditions, development of other product candidates, strategic transactions, partnerships, and other opportunities. TLANDOﾮ Lipocine has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved. Lipocine has entered into additional...

SALT LAKE CITY (AP) — SALT LAKE CITY (AP) — Lipocine Inc. (LPCN) on Thursday reported a loss of $3.7 million in its first quarter. The Salt Lake City-based company said it had a loss of 54 cents per share. The specialty pharmaceutical company posted revenue of $119,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LPCN at https://www.zacks.com/ap/LPCN

In the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60 (primary endpoint); the primary endpoint was not met In a post hoc analysis of participants (n=54) who had a history of psychiatric conditions, LPCN 1154 demonstrated nominal statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo as early as hour 12 and sustained through day 30 In the overall population, LPCN 1154 was well tolerated and demonstrated a differentiated safety profile with no reported adverse event, including somnolence or dizziness, occurring in more than 5% of the LPCN 1154-treated participants The Company plans to evaluate all available options going forward SALT LAKE CITY, April 2, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design, refer to clinicaltrials.gov: NCT06979544. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary was not met. The results showed LPCN 1154 to be well tolerated and demonstrated a favorable safety profile to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations were reported. In a post hoc analysis of participants with a history of psychiatric conditions diagnosed using Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen for and diagnose psychiatric disorders using DSM/ICD criteria), the Company identified signals that could indicate a potential development path for LPCN 1154. Table: Placebo-Adjusted HAM-D17 Score Change from Baseline NSS: Not Statistically Significant. Mixed model for repeated measures, least squares means placebo-adjusted difference. P-values are nominal...

SALT LAKE CITY (AP) — SALT LAKE CITY (AP) — Lipocine Inc. (LPCN) on Monday reported a loss of $2.4 million in its fourth quarter. The Salt Lake City-based company said it had a loss of 34 cents per share. The specialty pharmaceutical company posted revenue of $1.1 million in the period. For the year, the company reported a loss of $9.6 million, or $1.69 per share. Revenue was reported as $2 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LPCN at https://www.zacks.com/ap/LPCN

SALT LAKE CITY, March 10, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the full year ended December 31, 2025 and provided a corporate update. "We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we've made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team's commitment to delivering more effective treatments for patients in need," said Dr Mahesh Patel, Lipocine President and CEO. "We're excited about the near-term milestones ahead and remain committed to advancing our pipeline proficiently." Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) Lipocine is developing LPCN 1154, a rapid onset, short treatment duration oral product candidate comprising the neuroactive steroid brexanolone for the treatment of postpartum depression. The last patient completed the final study visit (Last Patient/Last Visit) in a confirmatory Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD in February 2026. The study enrolled 90 patients in total and top line results are expected early in April 2026. If successful, the Phase 3 trial is expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the U.S. which is expected in mid-2026. LPCN 2201 for Major Depressive Disorders (MDD) Lipocine is advancing LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral treatment option for MDD with the goal of improving outcomes without the limitations of existing therapies. LPCN 2201 is chemically identical to the endogenous human hormone allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 2101 for Epilepsy Lipocine is developing LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy, including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose significant treatment challenges under current standard of care. Two posters related to LPCN 2101 were presented at the 2025 American Epilepsy Society (AES) Annual Meeting that took place in De...

SALT LAKE CITY (AP) — SALT LAKE CITY (AP) — Lipocine Inc. (LPCN) on Thursday reported a loss of $3.2 million in its third quarter. On a per-share basis, the Salt Lake City-based company said it had a loss of 59 cents. The specialty pharmaceutical company posted revenue of $114,600 in the period. Its adjusted revenue was $115,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LPCN at https://www.zacks.com/ap/LPCN

SALT LAKE CITY, Nov. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter ended September 30, 2025 and provided a corporate update. Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) LPCN 1154 (oral brexanolone) is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of PPD. A Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD continues to enroll patients and top-line data is expected in the second quarter of 2026. A meeting of the independent Data Safety Monitoring Board (DSMB) overseeing this trial will take place to review safety data from the first one-third of participants who were randomized and completed the day seven follow up visit, and the Company plans to provide a safety update in November 2025 following the DSMB review. Lipocine believes data from the Phase 3 study will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. The Phase 3 trial is expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the U.S. which is expected in 2026. On July 9, 2025, Lipocine hosted a virtual R&D investor event to discuss the current treatment landscape and unmet needs in PPD. The event featured presentations by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York) and by company management. A replay of the webinar can be accessed here. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party for commercialization. LPCN 2101 for Epilepsy Lipocine is evaluating LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose significant treatment challenges under current standard of care. The Company may initiate a Phase 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization. Pre-clinical and Phase 1 studies have demonstrated promising PK results, safety...

SALT LAKE CITY (AP) — SALT LAKE CITY (AP) — Lipocine Inc. (LPCN) on Tuesday reported a loss of $2.2 million in its second quarter. The Salt Lake City-based company said it had a loss of 41 cents per share. The specialty pharmaceutical company posted revenue of $622,800 in the period. Its adjusted revenue was $623,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LPCN at https://www.zacks.com/ap/LPCN

SALT LAKE CITY, Aug. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Neuroactive Steroids LPCN 1154 (oral brexanolone product candidate) is a non-invasive, 48-hour treatment option targeted for rapid symptom relief of postpartum depression (PPD), a serious unmet medical need. LPCN 1154 could have advantages with respect to limitations on daily activities, treatment duration, and time to effect. During the second quarter, Lipocine began treating patients with PPD in the pivotal Phase 3 safety and efficacy study of LPCN 1154. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD, with topline results expected in the second quarter of 2026 and a 505(b)(2) New Drug Application (NDA) submission in the U.S. expected in mid-2026. On July 9, 2025, Lipocine hosted a virtual R&D investor event featuring a presentation by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York) discussing the current treatment landscape and unmet needs in PPD, followed by a company management presentation which reviewed the target attributes of LPCN 1154, provided a clinical development progress update including relevant data and rationale for success, and discussed next steps in the product development. A replay of the webinar can be accessed here. Lipocine may explore the possibility of partnering LPCN 1154 with a third party for commercialization. LPCN 2401 for Management of GLP-1 Agonist Use in Obesity LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist, a regulator of myostatin. It is expected to have a favorable benefit to risk profile as a non-invasive option as an adjunct to GLP-1 receptor agonist use for quality weight loss though improved body composition and/or as a monotherapy for weight maintenance and/or newly achieved glycemic status post cessation of GLP-1 receptor agonist use with demonstrated liver benefits. Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with appropriate body composition and functional endpoints...

SALT LAKE CITY, May 8, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2025 and provided a corporate update. Neuroactive Steroids Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies with demonstrated benefits to the liver. Based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population, reportedly the population most vulnerable to lean mass and functionality loss while on GLP-1 agonist treatment, with plans to include functionality measures. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. TLANDO® Lipocine has an exclusive License Agreement with Verity Pharma (Verity), entered into in 2024, under which Verity has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved. In April 2025, Lipocine entered into a license and supply agreement with Aché granting exclusive rights to market TLANDO® in Brazil. Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. Today, Aché's products reach more tha...

SALT LAKE CITY (AP) — SALT LAKE CITY (AP) — Lipocine Inc. (LPCN) on Thursday reported a loss of $1.9 million in its first quarter. On a per-share basis, the Salt Lake City-based company said it had a loss of 35 cents. The specialty pharmaceutical company posted revenue of $93,900 in the period. Its adjusted revenue was $94,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LPCN at https://www.zacks.com/ap/LPCN

SALT LAKE CITY, March 13, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the year ended December 31, 2024, and provided a corporate update. Oral Brexanolone LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the rapid treatment of postpartum depression (PPD). Lipocine held a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 to discuss the NDA submission package for LPCN 1154 (oral brexanolone) as a treatment for PPD. In the meeting, Lipocine was advised that the FDA believes that, in addition to the previously completed PK bridge data, a safety and efficacy study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025. The Company has completed registration stability studies required for NDA submission. A Phase 3 safety and efficacy study will provide the opportunity to generate safety and depression symptom relief data with LPCN 1154. Lipocine believes this data will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. In addition, the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive commercial opportunity with a high unmet need. In October 2024, Lipocine announced positive data from a quantitative EEG (qEEG) study of oral brexanolone. The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist for obesity manag...