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Lipocine Inc. - LPCN STOCK NEWS

Welcome to our dedicated page for Lipocine news (Ticker: LPCN), a resource for investors and traders seeking the latest updates and insights on Lipocine stock.

Lipocine Inc. (NASDAQ: LPCN) is a specialty pharmaceutical company that focuses on the development and commercialization of pharmaceutical products leveraging their proprietary Hydroance drug delivery technology. Founded in 1997 and headquartered in Salt Lake City, Utah, Lipocine aims to provide non-invasive delivery solutions for hormones and other compounds, particularly in the fields of metabolic and endocrine disorders.

The company's flagship product, TLANDO, is an oral testosterone replacement therapy approved by the FDA for conditions associated with a deficiency of endogenous testosterone, or hypogonadism, in adult males. Alongside TLANDO, Lipocine has a robust pipeline of products in various stages of clinical development:

  • LPCN 1144: Targeted for the treatment of non-cirrhotic NASH (nonalcoholic steatohepatitis).
  • LPCN 1148: Developed for managing symptoms associated with liver cirrhosis, including sarcopenia and hepatic encephalopathy.
  • LPCN 1154: An oral brexanolone for the treatment of postpartum depression.
  • LPCN 2101: Aimed at the treatment of epilepsy.
  • LPCN 2203: Targeted for the management of essential tremor.
  • LPCN 2401: An oral combination therapy for improved body composition in chronic weight management.

Lipocine's recent achievements include the completion of key clinical studies and pivotal pharmacokinetic (PK) studies supporting New Drug Application (NDA) submissions. The company reported a net income of $3.5 million for the first quarter of 2024, driven by licensing revenues.

Strategic partnerships are a cornerstone of Lipocine's business model. For example, their agreement with Verity Pharma for the commercialization of TLANDO has significantly bolstered their financial position. As of March 31, 2024, Lipocine had $24.6 million in unrestricted cash, cash equivalents, and marketable securities.

For more detailed information about Lipocine Inc., visit their website at www.lipocine.com.

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Clarus Therapeutics achieved a significant legal victory as Federal Circuit Judge William C. Bryson ruled in favor of Clarus, invalidating all patent claims asserted by Lipocine, Inc. (NASDAQ: LPCN). The court found Lipocine's claims lacked adequate written description. The lawsuit stemmed from Lipocine's 2019 infringement allegations related to Clarus's FDA-approved testosterone product, JATENZO. Clarus's Chairman, Dr. Robert Dudley, expressed satisfaction with the ruling and indicated the company would continue to focus on expanding its product pipeline.

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Lipocine Inc. (NASDAQ: LPCN) reported its first-quarter financial results for 2021, showcasing positive developments in its clinical programs. The company achieved significant results in the Phase 2 LiFT clinical study for LPCN 1144, successfully meeting primary endpoints in male NASH subjects. They raised approximately $28.7 million in a public offering and reported a reduced net loss of $3.4 million, improving from $5.8 million year-over-year. Research and administrative expenses also declined, while unrestricted cash reached $50 million, a notable increase from the previous quarter.

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Lipocine Inc. (NASDAQ: LPCN) has announced its participation in two upcoming virtual investor conferences. The M Vest LLC and Maxim Group Emerging Growth Virtual Conference will take place on March 18-19, 2021, with Lipocine presenting on March 17 at 9:00 AM ET. The Lytham Partners Spring 2021 Investor Conference is scheduled for March 30-April 1, 2021, with a presentation on March 30 at 5:00 PM ET. Details and webcasts of the presentations will be available on Lipocine's corporate website.

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Lipocine Inc. (NASDAQ: LPCN) announced its financial results for the year ending December 31, 2020, reporting a net loss of $21.0 million, or ($0.38) per diluted share, compared to a loss of $13.0 million in 2019. The company received tentative FDA approval for TLANDO, its oral testosterone product, and reported positive results from the Phase 2 LiFT study for LPCN 1144. Research and development expenses increased to $9.7 million, while general and administrative expenses rose to $8.2 million. As of December 31, 2020, Lipocine had $19.7 million in unrestricted cash.

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Lipocine Inc. (NASDAQ: LPCN) announced the publication of preclinical results supporting LPCN 1144's potential in treating non-alcoholic steatohepatitis (NASH) and hepatic fibrosis. The study, featured in the Journal of Endocrinological Investigation, demonstrated LPCN 1144's effectiveness in a high-fat diet-induced NASH rabbit model. Lipocine is advancing LPCN 1144 through clinical trials, with a Phase 2 study ongoing. The company focuses on metabolic and endocrine disorders, with an FDA-approved product pipeline including TLANDO and TLANDO XR.

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Lipocine Inc. (Nasdaq: LPCN) announced that clinical data on its lead candidate, TLANDO™, will be presented at the ENDO 2021 Conference from March 20-23, 2021. TLANDO is an oral testosterone replacement therapy for adult males with hypogonadism. Key presentations include assessments on liver health interventions and efficacy/safety of TLANDO. The FDA has given tentative approval for TLANDO to treat testosterone deficiency. Lipocine's pipeline also includes LPCN 1144, TLANDO XR, LPCN 1148, and LPCN 1107.

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Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced its participation in two upcoming virtual investor conferences: the Raymond James 42nd Annual Institutional Investors Conference from March 1-3, 2021, and the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. Lipocine will present at the Raymond James conference on March 1 at 11:40 AM EST, with a webcast available. The H.C. Wainwright session will begin on March 9 at 7:00 AM EST. The presentations will also be archived for 90 days on the company's website.

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Lipocine Inc. (NASDAQ:LPCN) announced the closing of an underwritten public offering of 16,428,571 shares at $1.75 each, generating approximately $28.7 million in gross proceeds. This offering included the full exercise of underwriters' options for 2,142,857 additional shares. The shares were issued under an effective shelf registration statement and the transaction was managed by Raymond James & Associates, Inc. and Ladenburg Thalmann & Co. Inc. Lipocine focuses on metabolic and endocrine disorders and has several drug candidates in its clinical pipeline.

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Lipocine (NASDAQ:LPCN) priced a public offering of 14,285,714 shares at $1.75 each, expected to close around January 28, 2021. The offering could generate approximately $25 million in gross proceeds. Underwriters hold a 30-day option for an additional 2,142,857 shares. Proceeds will primarily support general corporate purposes, including working capital. Raymond James is the sole book-running manager, with Ladenburg Thalmann as co-manager. The offering is conducted under an effective registration statement with the SEC.

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Lipocine Inc. (NASDAQ: LPCN) announced plans for an underwritten public offering of its common stock. The offering will also allow underwriters a 30-day option to purchase an additional 15% of the shares offered. The net proceeds are intended for general corporate purposes, including working capital and capital expenditures. This offering is made under an effective shelf registration statement previously filed with the SEC. There’s no assurance regarding the completion or specific terms of the offering due to market conditions.

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FAQ

What is the current stock price of Lipocine (LPCN)?

The current stock price of Lipocine (LPCN) is $4.87 as of December 20, 2024.

What is the market cap of Lipocine (LPCN)?

The market cap of Lipocine (LPCN) is approximately 26.7M.

What is Lipocine Inc.?

Lipocine Inc. is a specialty pharmaceutical company focused on developing and commercializing pharmaceutical products using their proprietary Hydroance drug delivery technology.

Where is Lipocine Inc. headquartered?

Lipocine Inc. is headquartered in Salt Lake City, Utah.

What is TLANDO?

TLANDO is an oral testosterone replacement therapy developed by Lipocine, approved by the FDA for treating hypogonadism in adult males.

What are some key products in Lipocine's pipeline?

Key products include LPCN 1144 for non-cirrhotic NASH, LPCN 1148 for liver cirrhosis, LPCN 1154 for postpartum depression, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, and LPCN 2401 for body composition in chronic weight management.

Has Lipocine formed any significant partnerships?

Yes, Lipocine has partnered with Verity Pharma for the commercialization of TLANDO, among other strategic partnerships.

What is Hydroance?

Hydroance is Lipocine's proprietary drug delivery technology designed to provide non-invasive delivery solutions for small polar organics and macromolecules.

What recent financial results has Lipocine reported?

For the first quarter of 2024, Lipocine reported a net income of $3.5 million, primarily driven by licensing revenues.

What is the status of LPCN 1154?

LPCN 1154 is in the final stages of clinical development for the treatment of postpartum depression, with an NDA submission expected by the end of 2024.

How much cash does Lipocine have on hand?

As of March 31, 2024, Lipocine had $24.6 million in unrestricted cash, cash equivalents, and marketable investment securities.

What type of disorders is Lipocine targeting with its products?

Lipocine is targeting metabolic and endocrine disorders, Central Nervous System (CNS) disorders, liver cirrhosis, essential tremor, epilepsy, postpartum depression, and obesity management.

Lipocine Inc.

Nasdaq:LPCN

LPCN Rankings

LPCN Stock Data

26.69M
5.19M
2.91%
9.96%
2.01%
Biotechnology
Pharmaceutical Preparations
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United States of America
SALT LAKE CITY