LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy... Read More

Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities similar to... Read More

Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY , March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal... Read More

SALT LAKE CITY , March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone). Lipocine... Read More

SALT LAKE CITY , March 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh V. Patel , President and Chief Executive Officer, will participate in a fireside chat and meet with investors at the 36 th Annual Roth Conference, to take place in Laguna Niguel, CA , on March 18 . Presentation Details Date:... Read More

Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing SALT LAKE CITY , Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical... Read More

SALT LAKE CITY , Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO® in the U.S. has been transitioned to its licensee Verity Pharma, effective February 1, 2024 , enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy... Read More

Lipocine to receive $11 million license fee Up to $259 million in development and commercial sales milestones Tiered royalties on net sales of licensed products up to 18% Commercialization of TLANDO transitions to Verity Pharma effective Feb.1 2024 Lipocine retains all rights for territories outside the United States and Canada , and all non-TRT rights globally SALT LAKE CITY , Jan. 18, 2024 /PRNewswire/ -- Lipocine Inc.... Read More

Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Dec. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present at the Biotech Showcase and host institutional investor and partnering meetings at this event and at a Corporate Access Event organized by... Read More

Results demonstrate improvements in sarcopenia and other clinically meaningful outcomes Patients converting from placebo to LPCN 1148 in the ongoing open label extension also showed improvement in sarcopenia SALT LAKE CITY , Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study... Read More

SALT LAKE CITY , Nov. 8, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the third quarter and nine months ended September 30, 2023 , and provided a corporate update. Clinical Program Highlights Neuroactive Steroids On... Read More

"Late Breaking" abstract scheduled for oral presentation on November 13 SALT LAKE CITY , Nov. 1, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®... Read More

Lipocine and FDA agreed on the acceptance criteria for the pivotal study which enables advancement of LPCN 1154 for postpartum depression (PPD) Company on track to initiate dosing in the pivotal study Q1'24 SALT LAKE CITY , Oct. 26, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced... Read More

SALT LAKE CITY , Oct. 23, 2023 /PRNewswire/ -- L ipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present and meet with investors at the H.C. Wainwright 7th Annual NASH Investor Conference, taking place virtually October 24, 2023 . Presentation Details Presenter: Dr. Benjamin Bruno, Senior Director, Clinical Development Date/... Read More

SALT LAKE CITY , Sept. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh Patel, President and Chief Executive Officer, will present and meet with investors at the 2023 Cantor Fitzgerald Global Healthcare Conference to take place September 26th to September 28th in New York City. Presentation Details... Read More

SALT LAKE CITY , Aug. 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced financial results for the second quarter and six months ended June 30, 2023 , and provided a corporate update. Clinical Program Highlights Neuroactive Steroids Lipocine announced positive topline results from a pilot pharmacokinetics ("PK") bridge... Read More

Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01) Fewer hepatic encephalopathy (HE) events of grade >1 in the LPCN 1148 treatment arm relative to placebo (P < 0.05) More patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05) LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo Conference call and webcast... Read More

SALT LAKE CITY , June 14, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced that Dr. Mahesh Patel , President and Chief Executive Officer, will present virtually and meet with investors at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual... Read More

Phase 2 proof-of-concept study of LPCN 1148 in male cirrhotic patients with sarcopenia is fully enrolled with topline 24-week results expected mid-2023 SALT LAKE CITY , June 7, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary technology platform to develop differentiated products, today announced that it... Read More

Identified dosing regimen that enables reliance on a single confirmatory pivotal pharmacokinetic (PK) study to establish efficacy for postpartum depression (PPD) and support NDA submission LPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse events Lipocine plans to initiate the confirmatory pivotal PK study in 2H 2023 Conference call and webcast today at 8:30am ET SALT LAKE CITY , May 16, 2023... Read More

SALT LAKE CITY , May 11, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the first quarter ended March 31, 2023 , and provided a corporate update. First Quarter Highlights Neuroactive Steroid for Depression Dosing was... Read More

LPCN 1154 is an oral formulation of brexanolone in development for the rapid relief of postpartum depression (PPD) Topline study results expected in H1 2023 SALT LAKE CITY , April 3, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced that the first... Read More

SALT LAKE CITY , March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the year ended December 31, 2022 and provided a corporate update. In 2022, Lipocine announced a new strategic direction, focusing on the development... Read More

SALT LAKE CITY , March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series B Preferred Stock, par value $0.0001 per share, for each outstanding share of the Company's common stock held of record as of 5:00 p.m.... Read More

Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Jan. 5, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced that its management will present at the Biotech Showcase and host institutional... Read More

Top-line 24-week results from proof-of-concept study expected mid-2023 SALT LAKE CITY , Dec. 19, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced that it has completed enrollment in its Phase 2 proof-of-concept ("POC") study evaluating the... Read More