Lipocine

Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. The firm is involved in applying oral drug delivery technology for the development of pharmaceutical products focusing on metabolic and endocrine disorders. It offers TLANDO, an oral testosterone replacement therapy. The company was founded in 2011 and is headquartered in Salt Lake City, UT.

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Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. It offers TLANDO, an oral testosterone replacement therapy. The company was founded on October 13, 2011 and is headquartered in Salt Lake City, UT.

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 (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.

Lipocine Announces Continued Commercialization of TLANDO® through Verity Pharmaceuticals

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. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, 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.

Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada

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 LifeSci Partners. Both in-person events will take place January 8 - 10, 2024, in San Francisco, California.

Lipocine to Present at Biotech Showcase 2024

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 evaluating LPCN 1148 are being presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, taking place in Boston MA. The results are featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine.

Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023

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 October 18, Lipocine completed a successful meeting with the FDA on LPCN 1154, which is in development for postpartum depression (PPD).

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023

"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® 2023, to take place in Boston MA,  November 10 to 14, 2023. Presentation Details Title                          Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in patients with cirrhosis Presenter:                Dr. Arun J.

Lipocine to Present Clinical Data on LPCN 1148 at The Liver Meeting® 2023

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 the completion of a meeting with the FDA and guidance for the appropriate acceptance criteria for the upcoming LPCN 1154 pivotal study. PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth.

Lipocine Completes Successful Meeting with FDA on LPCN 1154 in Postpartum Depression

SALT LAKE CITY , Oct. 23, 2023 /PRNewswire/ -- Lipocine 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.

Lipocine to Present at the H.C. Wainwright Annual NASH Investor Conference

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.

Lipocine to Present at the Cantor Fitzgerald Global Healthcare Conference

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 study of LPCN 1154 (oral brexanolone).

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2023

Lipocine (NASDAQ: LPCN ) stock is rising higher on Thursday after the company released positive results from a Phase 2 clinical trial. That trail covers the use of LPCN 1148 as a treatment for patients suffering from cirrhosis.

Why Is Lipocine (LPCN) Stock Up 32% Today?

Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P 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 today at 8:30am ET SALT LAKE CITY , July 27, 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 positive topline results from a Phase 2 clinical study of LPCN 1148. LPCN 1148 is an oral candidate under development for the clinical management of cirrhosis.

LPCN 1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis

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 Conference on June 26, 2023.

Lipocine to Present at H.C. Wainwright Annual Neuropsychiatry Virtual Conference

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 will present posters on LPCN 1148 and LPCN 1144 at the forthcoming European Association for the Study of the Liver (EASL) Congress 2023, to take place in Vienna, Austria, June 21 – 24, 2023. A multimodal treatment candidate for sarcopenia in men with decompensated cirrhosis: a randomized, placebo-controlled trial evaluating LPCN 1148 Lead author and presenter: Dr. Benjamin J.

Lipocine to Present LPCN 1148 and LPCN 1144 at the EASL Congress 2023

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 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), today announced positive topline results from a pilot clinical PK bridge study of LPCN 1154 (oral brexanolone) with a comparator, IV brexanolone. The pilot study is an important step in Lipocine's ongoing program to develop LPCN 1154 for PPD.

Positive Topline Clinical Results Support Streamlined Development Pathway for LPCN 1154, Lipocine's Oral Candidate for Rapid Relief of Depression

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 initiated in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) a neuroactive steroid product candidate that Lipocine is developing for postpartum depression ("PPD").

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2023

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 participant has been dosed in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) and approved injectable brexanolone.   The U.S. Food and Drug Administration (FDA) has agreed with Lipocine's proposal for establishing the efficacy and safety of LPCN 1154 in women with PPD through a clinical (pharmacokinetic) bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing.

First Subject Dosed in the Clinical Bridge Study with Lipocine Depression Candidate, LPCN 1154

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 of endogenous neuroactive steroids which have broad applicability in treating various CNS conditions.

Lipocine Announces Financial Results for the Year Ended December 31, 2022

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. Eastern Time on March 24, 2023.

Lipocine Announces Pro Rata Distribution of Series B Preferred Stock to its Holders of Common Stock

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 investor and partnering meetings at this event and a Corporate Access Event organized by LifeSci Partners. Both in-person events will take place January 9-11, 2023, in San Francisco, California.

Lipocine to Present at Biotech Showcase

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 therapeutic potential of LPCN 1148 for the management of decompensated cirrhosis of various etiologies. Lipocine intends to explore partnering LPCN 1148.

Lipocine Completes Enrollment of LPCN 1148 Phase 2 Study for Decompensated Cirrhosis

SALT LAKE CITY , Nov. 9, 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 financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update. "During the third quarter we announced a new strategic direction for Lipocine, which involves applying our validated technology to develop differentiated treatments for CNS disorders.

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2022

SALT LAKE CITY , Nov. 3, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating CNS disorders by leveraging its proprietary platform to develop differentiated products, today announced George Nomikos, M.D., Ph.D., has joined Lipocine as Chief Medical Officer and Spyros Papapetropoulos, M.D.

Lipocine Announces Senior Leadership Appointments to Advance its CNS-Focused Pipeline

SALT LAKE CITY , Oct. 11, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on leveraging its proprietary Lip'ral platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules focused on treating CNS disorders, announced today that it will present at the H.C. Wainwright 6th Annual NASH Investor Conference to be held virtually on October 17.

Lipocine to Present at H.C. Wainwright 6th Annual NASH Investor Conference

SALT LAKE CITY , Sept. 27, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on leveraging its proprietary Lip'ral platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules focused on treating CNS disorders, announced today that it will participate in the Cantor Neurology & Psychiatric Conference (October 6-7) in San Francisco.

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