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. (LPCN) is a clinical-stage biopharmaceutical innovator advancing oral therapies for endocrine and central nervous system disorders. This page serves as the definitive source for verified news and press releases related to Lipocine's product pipeline, clinical trials, and strategic developments.
Investors and industry professionals will find timely updates on key initiatives including progress in postpartum depression treatments (LPCN 1154), testosterone replacement therapy (TLANDO), and novel therapies for liver cirrhosis. Our curated news collection provides:
• Clinical trial milestones
• Regulatory updates
• Partnership announcements
• Scientific publications
All content is sourced directly from company filings and authorized communications, ensuring reliability for investment research. Bookmark this page for streamlined access to Lipocine's latest advancements in oral drug delivery technology and therapeutic development.
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.
Lipocine Inc. (NASDAQ: LPCN) reported financial results for Q2 2024 and provided a corporate update. Key highlights include:
1. Positive topline results for LPCN 1154 in postpartum depression, with NDA submission targeted for Q4 2024.
2. Encouraging Phase 2 results for LPCN 2401 in weight management, showing improved body composition.
3. Positive Phase 2 results for LPCN 1148 in cirrhosis management, presented at EASL Congress 2024.
4. Q2 2024 financial results: Net loss of $3.1 million ($0.56 per diluted share), compared to $3.6 million in Q2 2023. Revenue of $90,000 from royalties.
5. As of June 30, 2024, Lipocine had $22.5 million in cash and equivalents.
Lipocine has announced that its oral drug LPCN 1154 met bioequivalence criteria in a pivotal study comparing it to IV brexanolone for treating postpartum depression (PPD). The study met key pharmacokinetic (PK) parameters: Cmax, AUC0-t, and AUC0-∞. LPCN 1154 also showed no sedation or somnolence events and was well tolerated. The company aims to submit a New Drug Application (NDA) by the end of Q4 2024. PPD affects around 500,000 women in the U.S. annually, with a significant unmet need for effective, fast-acting oral treatments.
Lipocine announced the Phase 2 study results for LPCN 1148 in cirrhosis, presented at the EASL Congress 2024 in Milan, Italy.
The study, led by Dr. Arun J. Sanyal, demonstrated that LPCN 1148 significantly improved sarcopenia and hepatic encephalopathy (HE) over 52 weeks. This breakthrough was highlighted in the symposium 'Revolutionary Advances in Liver Disease Research' at the EASL Congress.
The detailed findings are accessible on Lipocine's corporate website.
Lipocine Inc. (NASDAQ: LPCN) announced financial results for Q1 2024, reporting $3.5M net income, $7.6M revenue, and positive clinical data for LPCN 1154, LPCN 1148, and LPCN 2401. The company also entered an exclusive license agreement for TLANDO with Verity Pharma, showing promising growth and development in its product pipeline.
Lipocine Inc. announced that data from the Phase 2 study of LPCN 1148 will be presented at the EASL Congress 2024 in Italy. The study shows improvement in sarcopenia and hepatic encephalopathy in cirrhosis patients.