LPCN Lipocine Inc.

1.32
-0.01  -1%
Previous Close 1.33
Open 1.33
52 Week Low 1.09
52 Week High 2.42
Market Cap $116,543,658
Shares 88,290,650
Float 86,149,561
Enterprise Value $76,853,275
Volume 347,106
Av. Daily Volume 972,111
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Upcoming Catalysts

Drug Stage Catalyst Date
LPCN 1144
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
LPCN 1154
Postpartum Depression
Phase 2
Phase 2
Phase 2 trial planned. Dosing to commence 4Q 2021.
TLANDO - LPCN 1021
Men with low testosterone (Low T)
Approved
Approved
FDA tentative approval announced December 8, 2020.
LPCN 1148
Liver cirrhosis
Phase 2
Phase 2
Phase 2 trial planned.
LPCN 1107
Prevention of preterm birth ("PTB").
Phase 3
Phase 3
Conduct food/fact effect study in preparation for Phase 3 trial.
LPCN 1111
Oral testosterone product
Phase 2b
Phase 2b
Phase 2b top-line data released September 2016. Seeking feedback from FDA regarding Phase 3 design.

Latest News

  1. NORTHBROOK, Ill., July 15, 2021 (GLOBE NEWSWIRE) -- Clarus and Lipocine (NASDAQ:LPCN) agreed to settle all outstanding claims in the patent infringement lawsuit brought against Clarus by Lipocine and to further resolve a patent interference between the parties. The action for patent infringement was brought by Lipocine against Clarus arising out of Clarus's marketing of JATENZO®, an oral testosterone replacement product. The interference action involves a Clarus patent application that was pending issuance by the USPTO.

    On May 25, 2021, Clarus's request for summary judgement of invalidity with respect to all of Lipocine's asserted patent claims in the lawsuit was granted. Under terms of the settlement announced today, Lipocine and Clarus…

    NORTHBROOK, Ill., July 15, 2021 (GLOBE NEWSWIRE) -- Clarus and Lipocine (NASDAQ:LPCN) agreed to settle all outstanding claims in the patent infringement lawsuit brought against Clarus by Lipocine and to further resolve a patent interference between the parties. The action for patent infringement was brought by Lipocine against Clarus arising out of Clarus's marketing of JATENZO®, an oral testosterone replacement product. The interference action involves a Clarus patent application that was pending issuance by the USPTO.

    On May 25, 2021, Clarus's request for summary judgement of invalidity with respect to all of Lipocine's asserted patent claims in the lawsuit was granted. Under terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v. Clarus Therapeutics, Inc., Civil Action No. 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware. Additionally, both parties have reached an agreement on the interference, captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 and presently pending in the USPTO. The terms of the settlement remain confidential but do not involve any payment by Clarus to Lipocine.

    About Clarus Therapeutics, Inc.

    Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus's first commercial product, JATENZO, was launched in early 2020. For more information, visit www.clarustherapeutics.com and www.jatenzo.com

    Forward-Looking Statements

    Certain statements made in this press release are "forward-looking statements" within the meaning of the federal securities laws, including statements about the parties' ability to close the proposed business combination and related transactions, the anticipated benefits of the proposed business combination, and the financial condition, results of operations, earnings outlook and prospects of Blue Water and/or the proposed business combination and related transactions and may include statements for the period following the consummation of the proposed business combination and related transactions. In addition, any statements that refer to projections (financial or otherwise), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

    The forward-looking statements are based on the current expectations of the management of Blue Water and Clarus Therapeutics, as applicable, and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Clarus Therapeutics' ability to increase sales of JATENZO, secure favorable reimbursement coverage for such sales and expand its product offerings to include a pipeline of androgen and metabolic therapies for men and women, including orphan indications; the ability to complete the proposed business combination and to obtain approval from Blue Water's stockholders or satisfy other closing conditions in the definitive merger agreement; the outcome of any legal proceedings that may be instituted against Blue Water or Clarus related to the merger agreement or the proposed transaction; the ability to maintain the listing of Blue Water's securities on a national securities exchange; the amount of any redemptions by existing holders of Blue Water's common stock; the ability to recognize the anticipated benefits of the business combination; other risks and uncertainties included under the header "Risk Factors" in the registration statement on Form S-4 to be filed by Blue Water, in the final prospectus of Blue Water for its initial public offering dated December 16, 2020 and in Blue Water's other filings with the SEC.

    Clarus Investor Relations Contact:

    Kara Stancell

    Clarus Therapeutics, Inc.

    555 Skokie Blvd., Suite 340

    Northbrook, IL 60062

    (847) 562-4300 X206

      ###

    About JATENZO

    Indication

    JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

    Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

    Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

    Limitation of use

    Safety and efficacy of JATENZO in males less than 18 years old have not been established.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASES IN BLOOD PRESSURE

    • JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
    • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.
    • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
    • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

    CONTRAINDICATIONS

    JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

    WARNINGS AND PRECAUTIONS

    • Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.
    • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
    • Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.
    • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
    • Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.
    • Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.
    • Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
    • Gynecomastia may develop and persist in patients being treated for hypogonadism.
    • Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
    • Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.
    • Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.
    • Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
    • Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.

    ADVERSE EVENTS

    The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

    These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com.

    © 2021 Clarus Therapeutics, Inc. All rights reserved.

     



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  2. SALT LAKE CITY, July 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies.

    Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware.   Additionally, both parties have reached an agreement on the interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

    About Lipocine Inc.

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the timing and results of ongoing litigation and our responses thereto and our ability to maintain and utilize our intellectual property. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, risks related to ongoing litigation relating to our intellectual property and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-settlement-with-clarus-therapeutics-301333955.html

    SOURCE Lipocine Inc.

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  3. SALT LAKE CITY, July 6, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Ladenburg Thalmann Healthcare Conference. The conference will be held virtually. Presentation details are below.

    Ladenburg Thalmann Healthcare Conference July 13-14

    Presentation time:      July 13, 2021 starting at 11:00am ET

    Webcast:     https://wsw.com/webcast/ladenburg7/lpcn/2414031 

    The webcast of this presentation will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.  

    About Lipocine Inc.

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-to-present-at-the-ladenburg-thalmann-healthcare-conference-301320441.html

    SOURCE Lipocine Inc.

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  4. SALT LAKE CITY, June 23, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data will be presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, on June 23-26, 2021. 

    1. Title: Oral LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects: Results of a Phase 2 randomized controlled study Low Testosterone in Males may Warrant Liver Health Assessment Intervention

    Session Type: Poster Session

    Category: NAFLD: Therapy

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T

    ePoster Session: June 25, 2021 11:30 a.m. C.E.T.



    2. Title: High prevalence of low normal or overtly hypogonadal levels of testosterone observed in histologically established NASH subjects in LiFT Study

    Session Type: Poster Session

    Category: NAFLD: Therapy

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T



    3. Title: LPCN 1144 improves body composition in biopsy-confirmed NASH patients

    Session Type: Poster Session

    Category: Late Breaker: General Hepatology

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1154 is an oral neurosteroid targeted for the treatment of depressive disorders. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.   

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-announces-presentations-at-the-international-liver-congress-2021-digital-event-301313079.html

    SOURCE Lipocine Inc.

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  5. SALT LAKE CITY, June 16, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Raymond James Human Health Innovation Conference. The conference will be held virtually. Presentation details are below.

    Raymond James Human Health Innovation Conference June 21-23

    Presentation time:       June 21, 2021 starting at 12:40 PM ET         

    Webcast link:              https://kvgo.com/rj-health/lipocine-inc-june-2021

    The webcast of this presentation will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.  

    About Lipocine Inc.

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-to-present-at-the-raymond-james-human-health-innovation-conference-301313327.html

    SOURCE Lipocine Inc.

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