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.
Lipocine Inc. (NASDAQ: LPCN) announced that the USPTO's Patent Trial and Appeal Board declared Interference No. 106,128 involving Lipocine's patent application against Clarus Therapeutics' application. The USPTO withdrew the Clarus application as part of this process. This decision continues a trend of favorable outcomes for Lipocine, following previous interferences that resulted in the cancellation of Clarus patents. Lipocine's CEO, Dr. Mahesh Patel, expressed satisfaction with the PTAB's ruling, which reinforces the strength of Lipocine's patent portfolio.
Lipocine Inc. (NASDAQ: LPCN) reported positive topline results from its Phase 2 LiFT study of LPCN 1144, an oral testosterone prodrug, in male subjects with biopsy-confirmed non-cirrhotic NASH. The study, involving 56 subjects, showed robust liver fat reduction and improved liver injury markers at 12 weeks, with no tolerability issues. LPCN 1144 demonstrated a significant average reduction in liver fat of up to 46.9% and over 63% of patients achieving a >30% reduction. An open label extension study is set to collect additional data up to 72 weeks.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the H.C. Wainwright BioConnect 2021 Conference, scheduled virtually from January 11-14, 2021. A webcast of their presentation will be accessible on-demand starting 6:00 am ET, January 11, for 90 days.
Lipocine is focused on metabolic and endocrine disorders and has several products in its pipeline, including TLANDO, which has received tentative FDA approval for hypogonadism. Other products under development address conditions like non-cirrhotic NASH and recurrent preterm birth.
Lipocine Inc. (NASDAQ: LPCN) announced the enrollment of patients into an open-label extension of its LPCN 1144 Phase 2 LiFT study. This decision follows significant interest from investigators and patients wishing to continue treatment. The LiFT study focuses on LPCN 1144's effects in non-cirrhotic non-alcoholic steatohepatitis (NASH) patients. The extension allows for up to 72 weeks of therapy to gather additional data on the long-term safety and tolerability of LPCN 1144. All participants in this phase will receive active treatment, eliminating the placebo control.
Lipocine Inc. (NASDAQ: LPCN) announced that the jury trial set for February 8, 2021, in its patent case against Clarus Therapeutics has been postponed due to COVID-19. The trial's rescheduling will depend on when jury trials can safely resume in Delaware. Lipocine claims that Clarus's product JATENZO® infringes on several of its patents. Lipocine's product pipeline includes TLANDO, LPCN 1144, and others, with TLANDO already receiving FDA tentative approval for treating hypogonadism in men.
Lipocine Inc. (NASDAQ: LPCN) announced that the FDA has granted tentative approval for TLANDO, its oral testosterone product for testosterone replacement therapy (TRT) in adult males. This approval follows a comprehensive review of TLANDO's quality, safety, and efficacy. However, TLANDO cannot receive final approval until the exclusivity period for a competing product, Jatenzo®, expires on March 27, 2022. Lipocine plans to pursue final approval and will conduct post-marketing studies regarding risks associated with TLANDO.
Lipocine Inc. (NASDAQ: LPCN) announced that an independent contractor made unauthorized statements on its website, falsely claiming that TLANDO was approved by the FDA. The company confirmed that TLANDO has not received final FDA approval. Upon discovering the erroneous posting, Lipocine promptly removed the incorrect information from its website to maintain accurate communication.
Lipocine Inc. (NASDAQ: LPCN) announced that the FDA is working towards action on TLANDO's New Drug Application (NDA) during the week of December 7, 2020, but cannot guarantee timely action. TLANDO is an oral testosterone product candidate for testosterone replacement therapy in adult males with hypogonadism. The company has also resubmitted its NDA for TLANDO, which is currently under review. Lipocine's pipeline includes several product candidates aimed at metabolic and endocrine disorders.
Lipocine Inc. (NASDAQ: LPCN) reported its Q3 2020 financial results, revealing a net loss of $4.3 million, up from $3.1 million in Q3 2019. R&D expenses increased to $2.5 million, primarily due to clinical study costs related to LPCN 1144. The company completed patient enrollment for the LPCN 1144 Phase 2 study, with top-line results due in January 2021. Cash resources grew to $18.8 million from $14.1 million at the end of 2019. Additionally, general and administrative expenses rose to $1.9 million, influenced by increased legal and personnel costs.
Lipocine Inc. (NASDAQ: LPCN) announced that the FDA is expected to take action on its TLANDO New Drug Application (NDA) around November 30, 2020. TLANDO is an oral testosterone product aimed at treating hypogonadism in adult males. The company has resubmitted its NDA, which is currently under FDA review. Lipocine's pipeline also includes other drug candidates like LPCN 1144 and TLANDO XR. However, the company warns that the FDA may not meet the expected timeline and that approval is not guaranteed.
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