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 |
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8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
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Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
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
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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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Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as plannedMore than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reportedTopline results are on track for the second quarter of 2026SALT 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 tr
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 ef
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. The poster features 20-week data from the previously completed Phase 2 trial and highlights the rapid improvement in body composition in participants with obesity taking LPCN 2401. Data from the study also showed LPCN 2401 improves live
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). The study is progressing on track with one-third of planned patients randomized. Topline results are anticipated in the second quarter of 2026.
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. Wainwright 27th Annual Global Investment Conference being held in-person and virtually on September 8-10, 2025. Presentation Details Time: Available from 7:00 a.m. EDT onwardsDate: Friday, September 5, 2025 Investors can register for the co
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. AES 2025 Annual Meeting: December 5-9, 2025 Atlanta, Georgia Title: Oral Toxicokinetics of a B
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 limitat
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 healthcar
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). To register, click here. PPD
New Drug Submission filed by Lipocine's licensing partner Verity PharmaOver 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunitySALT 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 titrat
Live Leadership Updates
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
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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 ef
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 limitat
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