• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
PublishGo to AppAI Helper
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI employees for your businessNEW
    Legal
    Terms of usePrivacy policyCookie policy

    Lipocine Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

    12/17/24 9:30:10 AM ET
    $LPCN
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $LPCN alert in real time by email
    false 0001535955 0001535955 2024-12-17 2024-12-17 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    FORM 8-K

     

    CURRENT REPORT

     

    Pursuant to Section 13 or 15(d) of

    The Securities Exchange Act of 1934

     

    Date of Report (Date of Earliest Event Reported):

    December 17, 2024

     

     

    LIPOCINE INC.

    (Exact name of registrant as specified in its charter)

     

    Commission File No. 001-36357

     

    Delaware   99-0370688

    (State or other jurisdiction

    of incorporation)

     

    (IRS Employer

    Identification Number)

     

    675 Arapeen Drive, Suite 202

    Salt Lake City, Utah 84108

    (Address of principal executive offices) (Zip Code)

     

    Registrant’s telephone number, including area code: (801) 994-7383

     

    Former name or former address, if changed since last report: Not Applicable

     

     

     

    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

     

    ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
       
    ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
       
    ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
       
    ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class   Trading Symbol(s)   Name of each exchange on which registered
    Common Stock, par value $0.0001 per share   LPCN   The NASDAQ Stock Market LLC

     

    Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).

     

    Emerging growth company ☐

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

     

     

     

     

     

    Item 8.01 Other Events

     

    The Company issued a press release announcing that the FDA has granted Fast Track Designation to LPCN 1148, as a treatment for sarcopenia in patients with decompensated cirrhosis. The press release is filed as Exhibits 99.1.

     

    Item 9.01 Financial Statements and Exhibits.

     

    (d) Exhibits

     

    The following exhibits are filed with this report:

     

    Exhibit No.   Description
    99.1   Press Release announcing FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis
         
    104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

     

     

     

    SIGNATURES

     

    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     

          LIPOCINE INC.
             
    Date: December 17, 2024   By: /s/ Mahesh V. Patel
            Mahesh V. Patel
            President and Chief Executive Officer
             
             

     

     

     

    Get the next $LPCN alert in real time by email

    Crush Q3 2025 with the Best AI Executive Assistant

    Stay ahead of the competition with Tailforce.ai - your AI-powered business intelligence partner.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Tailforce.ai

    Recent Analyst Ratings for
    $LPCN

    DatePrice TargetRatingAnalyst
    8/26/2021$2.50 → $3.50Buy
    HC Wainwright & Co.
    6/24/2021$3.00Overweight
    Cantor Fitzgerald
    More analyst ratings

    $LPCN
    SEC Filings

    See more
    • Lipocine Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

      8-K - Lipocine Inc. (0001535955) (Filer)

      7/9/25 11:01:32 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 8-K filed by Lipocine Inc.

      8-K - Lipocine Inc. (0001535955) (Filer)

      7/2/25 11:19:53 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Lipocine Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

      8-K - Lipocine Inc. (0001535955) (Filer)

      6/26/25 9:35:27 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression

      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

      6/26/25 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Lipocine to Host Virtual R&D Investor Event to Discuss LPCN 1154 (BRLIZIO™) as a Treatment for Postpartum Depression on July 9, 2025

      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

      6/23/25 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada

      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

      6/9/25 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • SEC Form 4 filed by Director Ono Richard Dana

      4 - Lipocine Inc. (0001535955) (Issuer)

      6/5/25 4:07:01 PM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Director Jene Jill M.

      4 - Lipocine Inc. (0001535955) (Issuer)

      6/5/25 4:06:49 PM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Director Papapetropoulos Spyros

      4 - Lipocine Inc. (0001535955) (Issuer)

      6/5/25 4:06:40 PM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

      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

      8/26/21 6:33:21 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Cantor Fitzgerald initiated coverage on Lipocine with a new price target

      Cantor Fitzgerald initiated coverage of Lipocine with a rating of Overweight and set a new price target of $3.00

      6/24/21 7:18:29 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

      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

      5/27/21 6:10:57 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    See more
    • FDA Approval for TESTOSTERONE UNDECANOATE issued to LIPOCINE INC

      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

      3/29/22 4:34:43 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • FDA Tentative Approval for TESTOSTERONE UNDECANOATE

      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

      12/20/20 4:30:41 PM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Leadership Updates

    Live Leadership Updates

    See more
    • LIPOCINE ANNOUNCES BOARD of DIRECTOR APPOINTMENTS

      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

      4/11/22 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • SEC Form SC 13G/A filed by Lipocine Inc. (Amendment)

      SC 13G/A - Lipocine Inc. (0001535955) (Subject)

      2/10/22 8:22:26 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G/A filed

      SC 13G/A - Lipocine Inc. (0001535955) (Subject)

      2/10/21 2:41:32 PM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G filed

      SC 13G - Lipocine Inc. (0001535955) (Subject)

      2/10/21 11:14:29 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $LPCN
    Financials

    Live finance-specific insights

    See more
    • Lipocine Announces Financial Results for the First Quarter Ended March 31, 2025

      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

      5/8/25 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Lipocine Announces Financial Results for the Full Year Ended December 31, 2024

      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

      3/13/25 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

      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

      11/7/24 8:00:00 AM ET
      $LPCN
      Biotechnology: Pharmaceutical Preparations
      Health Care