Lipocine Inc.LPCNNASDAQ

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Lipocine Announces Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

SALT LAKE CITY, Jan. 20, 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 enrollment and participant dosing have been completed in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). A total of 90 patients were randomized in the study.

globenewswire.com

2026 Asset Growth: Why Federal Compliance Is the New Metric

VANCOUVER, British Columbia, Jan. 19, 2026 (GLOBE NEWSWIRE) -- Equity-Insider. com News Commentary - Consumer healthcare markets hit a massive $362 billion entering 2026, but smart money is shifting toward regulatory certainty rather than just market size[1]. Modern health organizations are using aggressive buyouts as a primary 2026 strategy to secure high-tech efficiency while navigating intense federal scrutiny and capital limits[2].

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Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Company on track to report topline results early in the second quarter of 2026 Second planned Data and Safety Monitoring Board (DSMB) meeting evaluated all available safety data for the 82 randomized No drug discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs reported Study is no longer screening new participants SALT LAKE CITY, Jan. 12, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the second of two DSMB reviews planned during the study.

defenseworld.net

Critical Review: Lipocine (NASDAQ:LPCN) & Lyell Immunopharma (NASDAQ:LYEL)

Lyell Immunopharma (NASDAQ: LYEL - Get Free Report) and Lipocine (NASDAQ: LPCN - Get Free Report) are both small-cap medical companies, but which is the superior business? We will compare the two businesses based on the strength of their institutional ownership, earnings, risk, profitability, analyst recommendations, dividends and valuation. Analyst Recommendations This is a breakdown of recent

prnewswire.com

Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone

Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026 Topline results on track for the second quarter of 2026 SALT LAKE CITY , Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026.

prnewswire.com

Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY , Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit (n=30).

zacks.com

Lipocine (LPCN) Reports Q3 Loss, Tops Revenue Estimates

Lipocine (LPCN) came out with a quarterly loss of $0.59 per share versus the Zacks Consensus Estimate of a loss of $0.56. This compares to a loss of $0.44 per share a year ago.

prnewswire.com

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

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.

prnewswire.com

Lipocine Presents LPCN 2401 Clinical Data at ObesityWeek®

SALT LAKE CITY , Nov. 4, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the presentation of a poster Treatment with Oral LPCN 2401, a Physiological Regulator of Myostatin, Rapidly Improves Body Composition in Men with Obesity at the ObesityWeek® annual meeting, taking place in Atlanta, Ga., November 4 to 7.

prnewswire.com

Lipocine Provides Progress Update on LPCN 1154 Phase 3 Clinical Trial in Postpartum Depression (PPD)

One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY , Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).

prnewswire.com

Lipocine to Present at H.C. Wainwright 27th Annual Global Investment Conference

SALT LAKE CITY , Sept. 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 that Company Management will present and meet with investors at the H.C.

prnewswire.com

Lipocine Announces LPCN 2101 Abstracts Accepted for Presentation at AES 2025

SALT LAKE CITY , Aug. 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that two abstracts related to LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting to be held December 5-9 in Atlanta, Georgia. LPCN 2101 is in development for the potential treatment of epilepsy.

prnewswire.com

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2025

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.

prnewswire.com

Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression

Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY , June 26, 2025 /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 first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD). Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider.

prnewswire.com

Lipocine to Host Virtual R&D Investor Event to Discuss LPCN 1154 (BRLIZIO™) as a Treatment for Postpartum Depression on July 9, 2025

SALT LAKE CITY , June 23, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that it will host a virtual research and development (R&D) investor event on Wednesday, July 9, 2025 at 11:00 AM ET featuring Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who will join company management to discuss the current treatment landscape and unmet needs in postpartum depression (PPD).

prnewswire.com

Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada

New Drug Submission filed by Lipocine's licensing partner Verity Pharma Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity SALT LAKE CITY , June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.

prnewswire.com

Lipocine's LPCN 1148 Highlighted in the June 2025 Edition of Hepatology

SALT LAKE CITY , May 22, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that its development candidate LPCN 1148 for men with cirrhosis is featured in the "Hepatology Highlights" section of the June 2025 edition of Hepatology. The article "LPCN 1148: Rebuilding muscle memory in cirrhosis patients" was contributed by Dr. Kevin Harris of the Division of Gastroenterology and Hepatology, Mayo Clinic, Minnesota.

prnewswire.com

Lipocine to Present at A.G.P.'s Annual Healthcare Company Showcase

SALT LAKE CITY , May 14, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will present at A.G.P.'s Annual Healthcare Company Showcase being held virtually on Wednesday, May 21, 2025.

prnewswire.com

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2025

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).

prnewswire.com

Lipocine Announces License and Supply Agreement for TLANDO® in Brazil

SALT LAKE CITY , May 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that it has entered into license and supply agreement with Aché Laboratórios Farmacêuitcos S.A (Aché) granting exclusive rights to market TLANDO® in Brazil. The market for prescription testosterone products in Brazil is substantial and rapidly growing with compound annual growth rate (CAGR) of 34% from 2019 to 2023 and no oral testosterone therapy registered in Brazil.

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