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) will present at the H.C. Wainwright 23rd Annual Global Investment Conference virtually from September 13-15, 2021. The presentation is scheduled for September 13, 2021, starting at 7:00 a.m. EST. Investors can access the webcast through the conference portal or Lipocine's website. The presentation will be available on-demand for 90 days. Lipocine focuses on metabolic and endocrine disorders, with products like TLANDO and LPCN 1144 addressing various testosterone-related conditions.
Lipocine Inc. (NASDAQ: LPCN) announced positive topline results from its Phase 2 LiFT clinical study of LPCN 1144 in men with biopsy-confirmed NASH. The study met its primary endpoint, demonstrating a statistically significant reduction in liver fat after 12 weeks, with a mean absolute reduction of 9.2% and a relative reduction of 46.8% compared to placebo. Both treatment arms also showed significant improvements in NASH without worsening fibrosis and favorable safety profiles. The company is planning to discuss potential accelerated approval with the FDA.
Lipocine Inc. (NASDAQ: LPCN) announced its financial results for Q2 2021, reporting a net loss of $6.8 million or ($0.08) per diluted share, a reduction from a net loss of $6.4 million in Q2 2020. Research and development expenses decreased to $1.5 million, primarily due to reduced costs in the LPCN 1144 clinical study. Significant corporate highlights include positive topline results from the Phase 2 LiFT study, FDA clearance for LPCN 1154's IND, and an upcoming proof-of-concept study for postpartum depression.
Lipocine Inc. (NASDAQ: LPCN) announced a global settlement with Clarus Therapeutics to resolve ongoing intellectual property litigation. The agreement includes the dismissal of the Lipocine Inc. v Clarus Therapeutics, Inc. case in the U.S. District Court and the interference proceedings in the U.S. Patent and Trademark Office. Although the specific terms remain confidential, this development could allow Lipocine to focus more on its pipeline of drug candidates, including TLANDO and LPCN 1144, which are in various stages of clinical development for metabolic and endocrine disorders.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced its participation in the Ladenburg Thalmann Healthcare Conference on July 13, 2021, at 11:00 am ET. The conference will be held virtually, and interested parties can access the webcast here. Lipocine is focused on metabolic and endocrine disorders and has a pipeline including TLANDO, a testosterone treatment that has received FDA tentative approval. For further details, visit www.lipocine.com.
Lipocine Inc. (Nasdaq: LPCN) announced the presentation of clinical data at The International Liver Congress™ 2021 from June 23-26, 2021. The presentations will detail the efficacy of LPCN 1144 in reducing liver fat and improving body composition in non-alcoholic steatohepatitis (NASH) subjects. Key findings include significant reductions in liver injury markers and low testosterone levels in NASH patients. These results may highlight LPCN 1144's potential in treating liver health issues associated with low testosterone, enhancing Lipocine's clinical development pipeline.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the Raymond James Human Health Innovation Conference from June 21-23, 2021. The presentation is scheduled for June 21 at 12:40 PM ET. Interested parties can access the webcast here. The company focuses on metabolic and endocrine disorders, with key products including TLANDO, LPCN 1144, and others aimed at treating conditions such as hypogonadism and non-cirrhotic NASH.
Lipocine Inc. (Nasdaq: LPCN) announced FDA clearance for its Investigational New Drug Application to begin a Phase 2 study of LPCN 1154, an oral neuro-steroid for treating postpartum depression (PPD). The pharmacokinetic study is set to start in July 2021, with results expected by Q3 2021, followed by a proof-of-concept study later in Q4 2021. PPD affects 1 in 7 women post-birth, and LPCN 1154 aims to provide a non-invasive treatment option, likely benefiting breastfeeding mothers.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced its participation in the Lytham Partners Summer 2021 Investor Conference from June 14-16, 2021. The company will present on June 14, starting at 3:30 PM ET. Interested parties can access the webcast here. Lipocine focuses on metabolic and endocrine disorders, with notable products in its pipeline including TLANDO and LPCN 1144, aimed at treating testosterone deficiencies and non-cirrhotic NASH, respectively.
On May 26, 2021, Lipocine (NASDAQ: LPCN) announced the U.S. District Court for Delaware granted Clarus Therapeutics' motion for Summary Judgment, invalidating Lipocine's patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 due to inadequate written description. Despite this setback, Lipocine continues to affirm the strength of its intellectual property and is evaluating further actions. The company’s pipeline includes TLANDO and LPCN 1144, with various clinical studies underway for treating metabolic and endocrine disorders.
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