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 its management team will present at the Biotech Showcase and participate in the LifeSci Partners Corporate Access Event from January 9-11, 2023, in San Francisco. The presentation is scheduled for January 11 at 9 AM PT at the Hilton Hotel Union Square. Investors can attend in person or via webcast. Lipocine focuses on CNS disorder treatments and is exploring partnerships for various product candidates, including LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy.
Lipocine Inc. (NASDAQ: LPCN) has completed enrollment in its Phase 2 proof-of-concept study for LPCN 1148, targeting decompensated cirrhosis, with top-line results expected in mid-2023. The study focuses on the effects of LPCN 1148 on improving muscle function and outcomes in cirrhotic patients. This condition affects over 500,000 Americans annually, with high mortality rates. The ongoing research is vital as it addresses a significant unmet medical need, and the company plans to explore potential partnerships for LPCN 1148.
Lipocine Inc. (NASDAQ: LPCN) announced its Q3 and nine-month financial results for 2022, reporting a net loss of $2.4 million ($0.03 per diluted share) for Q3, an improvement from $3.1 million ($0.04 per diluted share) in Q3 2021. Revenues remained flat at $0, down from $55,000 in the previous year. R&D expenses decreased to $2.1 million, while G&A expenses fell to $0.8 million. As of September 30, 2022, cash reserves stood at $34.3 million, down from $46.6 million at year-end 2021. The company is shifting focus to CNS disorders, notably postpartum depression treatment LPCN 1154.
Lipocine Inc. (NASDAQ: LPCN) has announced key leadership appointments, with George Nomikos, M.D., Ph.D. appointed Chief Medical Officer and Spyros Papapetropoulos, M.D., Ph.D. as Lead Director and Chairman of the Board. The FDA has agreed to Lipocine's plan to establish the efficacy of LPCN 1154 for postpartum depression via a pivotal pharmacokinetic study. A pilot study has started, with results expected in the first half of 2023. LPCN 1154 aims to be the fastest acting oral treatment for postpartum depression, enhancing Lipocine's focus on CNS disorders.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022, at 3:30 p.m. EST. The conference will be held virtually, and interested investors can arrange 1x1 meetings with representatives. Lipocine focuses on developing oral delivery products for CNS disorders using its proprietary Lip'ral platform. Key clinical candidates include LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy. Lipocine also explores partnerships for several other treatment candidates.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the Cantor Neurology & Psychiatric Conference taking place on October 6-7, 2022 in San Francisco. The conference will be held at the Ritz Carlton Hotel, where investors can arrange 1x1 meetings. Lipocine focuses on developing products for CNS disorders through its proprietary Lip'ral platform, with candidates in development like LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy. The company aims to provide effective oral delivery options for significant medical needs.
Lipocine Inc. (NASDAQ: LPCN) announced a strategic focus on developing treatments for Central Nervous System (CNS) disorders using its proprietary Lip'ral oral drug delivery technology. The initial target is LPCN 1154, an oral neuroactive steroid for postpartum depression (PPD). The FDA has agreed on a pivotal pharmacokinetic study to establish efficacy via a 505(b)(2) NDA filing. Lipocine plans to explore partnerships to advance non-core products, ensuring efficient resource management. As of June 30, 2022, the company had $37.4 million in cash, sufficient for operations until at least September 30, 2023.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the Ladenburg Thalmann 2022 Healthcare Conference, scheduled for September 29, 2022, in New York. The presentation will take place from 3:00 to 3:25 p.m. EST at the Sofitel Hotel. The company focuses on enhancing therapeutics through its Lip'ral platform, developing oral delivery options for conditions like postpartum depression and liver cirrhosis. Interested investors can arrange 1x1 meetings through their Ladenburg Thalmann representatives.
Lipocine has received FDA agreement to establish efficacy for LPCN 1154, an oral formulation for postpartum depression (PPD). The drug is based on brexanolone, with exposure similar to that seen in pregnant women. A pivotal pharmacokinetic (PK) bridge study is set for 4Q 2022, with results expected in 1Q 2023. This could lead to the first oral treatment option for PPD, addressing significant market needs. Lipocine's technology platform aims to create accessible therapies, potentially revolutionizing PPD treatment.
Lipocine (NASDAQ: LPCN) reported its Q2 2022 financial results with a net loss of $2.6 million, improving from a loss of $6.8 million in Q2 2021. Revenues were $0.5 million from a non-refundable fee related to LPCN 1111. R&D expenses rose to $2.9 million due to ongoing studies, including LPCN 1148 and LPCN 1154. The company has $37.4 million in cash as of June 30, 2022, down from $46.6 million at year-end 2021. Key developments include the launch of TLANDO™ and progress with FDA-approved studies for LPCN 1144 and LPCN 2101.
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