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 |
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
4 - Lipocine Inc. (0001535955) (Issuer)
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. 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
Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulationRapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disordersSALT LAKE CITY, Oct. 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being de
SALT LAKE CITY, Oct. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced an exclusive supply and distribution agreement with Pharmalink https://pharmalink.ae/ to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. Under the terms of the agreement, Lipocine received an upfront
SALT LAKE CITY, Oct. 2, 2024 /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 host a virtual key opinion leader (KOL) event on LPCN 2401 for improved body composition in obesity management on Wednesday, October 16, 2024 at 11:00 am ET. To register, click here. The event will feature Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center), who will discuss the unmet needs and curren
SALT LAKE CITY, Sept. 30, 2024 /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 and meet with investors at the H.C. Wainwright 8th Annual MASH Investor Conference, to take place virtually on October 7, 2024. Presentation Details Time: 2:00 to 2:30pm ET Date: Monday, October 7, 2024 Webcast Link: https://journey.ct.events/view/c252f9f3-ea24-4af7-a747-6fcef1e58f4f Investors can register for the conference here. Tho
Study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity SALT LAKE CITY, Sept. 5, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that a poster featuring Phase 2 data on LPCN 2401 will be presented at the Obesity Society's Annual ObesityWeek® conference to be held November 3 – 6, 2024 in San Antonio, TX. Presentation Details Title Oral LPCN 2401 Re
SALT LAKE CITY, Aug. 27, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer, will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually on September 9-11, 2024. Presentation Details Time: Available from 7:00 a.m. EDT onwardsDate: Monday, Sept
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
Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞Ctrough criterion was metLPCN 1154 was well tolerated with no sedation or somnolence events observedOn track for NDA filing, targeted by end of Q4 2024
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Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial" was presented by Arun J. Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. The presentation is featured in the symposium "Revolutionary Advances in Liver Disease Research Unv
Lipocine (NASDAQ:LPCN) reported quarterly earnings of $0.66 per share. This is a 186.84 percent increase over losses of $(0.76) per share from the same period last year. The company reported $7.50 million in sales this quarter. This is a 13.54K percent increase over sales of $54.99 thousand the same period last year.
Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company, today announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy.Presentation DetailsTitle Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy ("HE") in patients with cirrhosis: a 52-week phase 2 randomized clinical trialPresenter: Dr. Arun J. Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth UniversitySession Title: Late BreakerSession Date and Time: Saturday, 8 June, 14:00 -
Gainers Eliem Therapeutics (NASDAQ:ELYM) stock moved upwards by 51.6% to $4.05 during Thursday's pre-market session. The market value of their outstanding shares is at $112.2 million. Rallybio (NASDAQ:RLYB) stock increased by 49.07% to $2.43. The company's market cap stands at $91.8 million. Alpine Immune Sciences (NASDAQ:ALPN) shares rose 36.62% to $64.27. The company's market cap stands at $4.2 billion. IMAC Hldgs (NASDAQ:BACK) stock increased by 22.41% to $3.44. The market value of their outstanding shares is at $3.9 million. Healthcare Triangle (NASDAQ:HCTI) shares rose 15.3% to $1.77. The market value of their outstanding shares is at $8.2 million. Lipocine (NASDAQ:LPCN) stock ros
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
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
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
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 HighlightsNeuroactive Steroid for DepressionDosing was initiated in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) a neuroactive steroid product candidate that Lipocine is developing for postpartum depressio
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. The Company is currently exploring partnering non-core
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10-Q - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)
8-K - Lipocine Inc. (0001535955) (Filer)