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 (NASDAQ: LPCN) has received Fast Track Designation from the FDA for LPCN 1148, targeting sarcopenia treatment in patients with decompensated cirrhosis. The designation follows positive results from a Phase 2 proof-of-concept study where LPCN 1148, an oral prodrug of bioidentical testosterone, demonstrated improvements in sarcopenia and associated clinical outcomes.
LPCN 1148 aims to be a 'First in Class' treatment where no current therapy exists. The Fast Track status enables benefits including more frequent FDA meetings, enhanced communication about clinical trial design, eligibility for Accelerated Approval and Priority Review, and Rolling Review submission options for the New Drug Application (NDA).
Lipocine announced the publication of LPCN 1148's Phase 2 clinical trial results in Hepatology journal and its discussion at The Liver Meeting 2024. The study evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. At 24 weeks, LPCN 1148 showed significant improvement in sarcopenia compared to placebo and resulted in fewer episodes of overt hepatic encephalopathy (OHE), despite patients being on background therapies. The treatment also demonstrated beneficial effects on muscle quality, hemoglobin, and patient-reported symptoms. LPCN 1148 is positioned as a potential 'First in Class' product for OHE and sarcopenia indications.
Lipocine Inc (NASDAQ: LPCN) reported Q3 2024 financial results with a net loss of $2.2 million ($0.44 per share), compared to a $6.7 million loss in Q3 2023. The company had $19.8 million in cash and equivalents as of September 30, 2024. Key developments include positive results from LPCN 1154's qEEG study for postpartum depression treatment, with NDA submission targeted for end of 2024. Lipocine signed exclusive distribution agreements for TLANDO in GCC countries and South Korea. For the nine months ended September 30, 2024, revenue was $7.7 million, primarily from licensing, with a net loss of $1.8 million.
Lipocine Inc. (NASDAQ: LPCN) has entered into a license, development and supply agreement with SPC Korea for exclusive marketing rights of TLANDO® in South Korea. The agreement includes an upfront payment, potential regulatory and sales milestone payments, royalties on net commercial sales, and a supply price arrangement. SPC Korea will be responsible for obtaining regulatory approval in South Korea. This partnership aims to expand TLANDO's global reach and address unmet medical needs in the South Korean market.
Lipocine Inc. (NASDAQ: LPCN) announced positive data from its quantitative Electroencephalogram (qEEG) study of oral brexanolone, a neuroactive steroid being developed for post-partum depression (PPD). The study, conducted on 12 healthy postmenopausal females, showed robust central nervous system (CNS) activity with concentration- and time-dependent post-dose changes in qEEG.
Key findings include:
- Significant increases in theta and alpha1 band power in posterior cortical regions
- Decrease in alpha2 band power
- Considerable beta band amplitude increase across all cortical brain areas
- Rapid onset of effects (as early as 2 hours) with maximum impact at 4 hours post-dose
- Effects lasting up to 12 hours post-dose
These results confirm GABAA positive allosteric modulation and support the potential utility of oral brexanolone in treating various neuropsychiatric indications, including depression, anxiety, essential tremor, and epilepsy. The safety profile was consistent with previous clinical studies, showing minimal CNS depressant effects.
Lipocine Inc. (NASDAQ: LPCN) has announced an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries. The agreement covers Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman.
Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink. Upon obtaining Marketing Authorizations in individual GCC countries, Lipocine will provide TLANDO drug product to Pharmalink at an agreed transfer price. Pharmalink will have exclusive rights to TLANDO in the GCC region and will be responsible for promotion, distribution, and sale of the product in the territory.
This partnership aligns with Lipocine's global strategy to expand the availability of TLANDO and make it broadly accessible. Pharmalink's expertise and established network in the GCC region make them an ideal partner to support the adoption and growth of TLANDO in these markets.
Lipocine Inc. (NASDAQ: LPCN) is set to host a virtual key opinion leader (KOL) event on October 16, 2024 at 11:00 am ET, focusing on LPCN 2401 for improved body composition in obesity management. The event will feature Dr. Frank Greenway, Professor and Chief Medical Officer at Pennington Biomedical Research Center, who will discuss unmet needs and current treatments in obesity management, emphasizing fat loss and lean muscle mass preservation for patients on incretin therapies.
The presentation will also cover positive data from the Phase 2 study of LPCN 2401, an oral proprietary androgen receptor agonist. The study showed significant improvements in body composition, suggesting potential use as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation. A live Q&A session will follow the formal presentation.
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on oral drug delivery, has announced its participation in the H.C. Wainwright 8th Annual MASH Investor Conference. The virtual event is scheduled for October 7, 2024.
Key details of Lipocine's presentation include:
- Time: 2:00 to 2:30pm ET
- Date: Monday, October 7, 2024
- Webcast Link: Available on the company's website
Investors can register for the conference through the provided link. Those interested in one-on-one meetings with Lipocine representatives are advised to contact their H.C. Wainwright representative to arrange such meetings.
Lipocine Inc. (NASDAQ: LPCN) announced that Phase 2 data on its drug candidate LPCN 2401 will be presented at the ObesityWeek® conference in San Antonio, TX, from November 3-6, 2024. The study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and those with BMI ≥27 with at least one weight-related comorbidity. The poster presentation, titled 'Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity,' will be delivered by Dr. Frank Greenway on November 5, 2024, at 2:30 pm CT in Exhibit Hall 4B. This presentation highlights Lipocine's efforts in developing oral therapeutics for obesity treatment.
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company specializing in oral drug delivery, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event, scheduled for September 9-11, 2024, will be held both in-person and virtually.
Dr. Mahesh V. Patel, President and CEO of Lipocine, will present at the conference and meet with investors. The presentation will be available from 7:00 a.m. EDT on Monday, September 9, 2024. Interested parties can access the webcast through the provided link. Investors wishing to arrange one-on-one meetings with Lipocine representatives should contact their H.C. Wainwright representative.
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