Lipocine Inc., a clinical-stage biopharmaceutical company, focuses on the development of pharmaceutical products for the treatment of metabolic and endocrine disorders. Its primary development programs are based on oral delivery solutions for poorly bioavailable drugs. The company has a portfolio of product candidates designed to produce pharmacokinetic characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability. Its lead product candidate is TLANDO, an oral testosterone replacement therapy. The company's pipeline candidates also include LPCN 1144, an oral prodrug of bioidentical testosterone that is in Phase II Clinical trial for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH); TLANDO XR, an oral prodrug of testosterone for once daily dosing, which has completed Phase II clinical trial in hypogonadal men; LPCN 1148, an oral prodrug of bioidentical testosterone that has completed phase I clinical trial for the treatment of NASH cirrhosis; and LPCN 1107, an oral hydroxyprogesterone caproate product that has completed dose finding Phase II clinical trial for the prevention of recurrent preterm birth. The company is headquartered in Salt Lake City, Utah.
IPO Year:
Exchange: NASDAQ
Website: lipocine.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 8/26/2021 | $2.50 → $3.50 | Buy | HC Wainwright & Co. |
| 6/24/2021 | $3.00 | Overweight | Cantor Fitzgerald |
SC 13G/A - Lipocine Inc. (0001535955) (Subject)
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HC Wainwright & Co. reiterated coverage of Lipocine with a rating of Buy and set a new price target of $3.50 from $2.50 previously
Cantor Fitzgerald initiated coverage of Lipocine with a rating of Overweight and set a new price target of $3.00
HC Wainwright & Co. reiterated coverage of Lipocine with a rating of Buy and set a new price target of $2.50 from $3.00 previously
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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 s
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 Braz
48 hour at-home dosing Patient dosing expected in Q2/2025SALT LAKE CITY, March 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD). Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic (PK) bridge study, the company is initiating a phase 3 s
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 2
SALT LAKE CITY, March 12, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post market ambulatory blood pressure (ABPM) studies.
SALT LAKE CITY, Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of
SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a "First in Class"
SALT LAKE CITY, Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia i
SALT LAKE CITY, Nov. 7, 2024 /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 and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option.The Company has completed labeling
SALT LAKE CITY, Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea http://spcpharm.co.kr granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory
Submission status for LIPOCINE INC's drug TESTOSTERONE UNDECANOATE (ORIG-1) with active ingredient TESTOSTERONE UNDECANOATE has changed to 'Approval' on 03/28/2022. Application Category: NDA, Application Number: 208088, Application Classification: Type 3 - New Dosage Form
Submission status for LIPOCINE INC's drug TESTOSTERONE UNDECANOATE (ORIG-1) with active ingredient TESTOSTERONE UNDECANOATE has changed to 'Tentative Approval' on 12/08/2020. Application Category: NDA, Application Number: 208088, Application Classification: Type 3 - New Dosage Form
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 s
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 2
SALT LAKE CITY, Nov. 7, 2024 /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 and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option.The Company has completed labeling
SALT LAKE CITY, Aug. 8, 2024 /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 second quarter ended June 30, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression (PPD) In June 2024, Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154. LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observedThe Company is targeting NDA subm
SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depressionThe FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through
LPCN 2401 treatment resulted in statistically significant body composition improvement in menIncreased 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 placeboPotential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy post discontinuationConference call and webcast at 8.30 a.m. ET todaySALT LAKE CITY, April 11, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company, today announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral
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 is developing LPCN 1154 for postpartum depression ("PPD")The bridge study results demonstrated comparative pharmacokinetics of LPCN 1154 to an approved IV in
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 is developing LPCN 1154 for postpartum depression ("PPD")The bridge study results demonstrated comparative ph
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 placeboConference call and webcast today at 8:30am ETSALT 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 posi
Identified dosing regimen that enables reliance on a single confirmatory pivotal pharmacokinetic (PK) study to establish efficacy for postpartum depression (PPD) and support NDA submissionLPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse eventsLipocine plans to initiate the confirmatory pivotal PK study in 2H 2023 Conference call and webcast today at 8:30am ETSALT 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 1
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Industry veterans Jill M. Jene, Ph.D. and Spyros Papapetropoulos M.D. Ph.D. appointed to Board SALT LAKE CITY, April 11, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company focused on neuroendocrine and metabolic disorders, announced today the appointment of Jill M. Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its board of directors. "We are very pleased to welcome Jill Jene and Spyros Papapetropoulos to our board of directors. Each of them brings a wealth of relevant expertise," said Mahesh V. Patel, Ph.D., Chairman and CEO of Lipocine. "J