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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Lipocine Inc. (LPCN) announced that Dr. Mahesh V. Patel, President and CEO, will participate in a fireside chat at the 36th Annual Roth Conference on March 18, 2024. The event will take place in Laguna Niguel, CA, with details provided for investors to attend or arrange meetings. The company's focus on CNS disorders is highlighted, emphasizing its commitment to engaging with investors.
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Lipocine Inc. announces positive results from a multi-dose clinical study confirming the 48-hour dosing regimen for LPCN 1154, an oral neurosteroid for the treatment of postpartum depression. The company is on track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing. The results support the design of the planned NDA enabling pivotal study, positioning LPCN 1154 as a highly effective, oral, fast-acting, and short-duration treatment option for PPD.
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Lipocine Inc. announced the transition of TLANDO® commercialization to Verity Pharma, ensuring patient access to the first oral testosterone replacement therapy approved by the FDA. The exclusive license agreement with Gordon Silver Limited will see Lipocine receive a total of $11 million, with $5 million already received and future payments of $2.5 million and $1 million by January 2025 and 2026, respectively.
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Lipocine Inc. (NASDAQ: LPCN) has entered into an exclusive licensing agreement with Verity Pharmaceuticals, Inc. (Verity Pharma) for the commercialization of TLANDO, the first and only oral testosterone replacement therapy (TRT) option approved by the US FDA that does not require dose titration. The agreement includes an $11 million license fee, up to $259 million in development and sales-based commercial milestone payments, and tiered royalties on net sales of TLANDO franchise products. Verity Pharma will be responsible for regulatory and marketing obligations in the U.S. and Canada, while Lipocine retains all rights to the TLANDO franchise for territories outside the U.S. and Canada, and all rights to non-TRT indications globally.
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Lipocine Inc. (NASDAQ: LPCN) to present at the Biotech Showcase and host institutional investor and partnering meetings at the event and at a Corporate Access Event organized by LifeSci Partners on January 8 - 10, 2024, in San Francisco, California.
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Lipocine Inc. (NASDAQ: LPCN) announces positive results of its Phase 2 study evaluating LPCN 1148 for sarcopenia and other clinically meaningful outcomes at The Liver Meeting 2023. The study demonstrates improvements in sarcopenia and hepatic encephalopathy, with an ongoing open label extension showing continued improvement in patients converting from placebo to LPCN 1148. Dr. Arun Sanyal, MD, presents the results at the conference, with an Open Label Extension ongoing and further data expected in Q1 2024.
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Lipocine Inc. (NASDAQ: LPCN) announced Q3 2023 financial results and a corporate update. The company reported a net loss of $6.7 million for Q3 2023, recognized a non-cash minimum guaranteed royalties revenue reversal of $3.1 million, and had $23.8 million of unrestricted cash. Clinical highlights include LPCN 1154's successful meeting with the FDA for postpartum depression treatment and positive topline results from the Phase 2 study of LPCN 1148 in liver cirrhosis.
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Lipocine Inc. announced that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The Liver Meeting® 2023. The presentation will focus on how LPCN 1148 improves sarcopenia and hepatic encephalopathy in patients with cirrhosis. Dr. Arun J. Sanyal will be the presenter. The presentation will take place on November 13, 2023, at 2:45 PM ET.
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Lipocine Inc. has announced that it has reached an agreement with the FDA on the acceptance criteria for the pivotal study of LPCN 1154, a potential treatment for postpartum depression. The company plans to initiate dosing in the study in Q1'24.
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Lipocine Inc. will present and meet with investors at the H.C. Wainwright 7th Annual NASH Investor Conference on October 24, 2023.
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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
United States of America
SALT LAKE CITY