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) 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.
Lipocine Inc. announced the completion of dosing in a pivotal study for LPCN 1154, an oral brexanolone for postpartum depression. The study aims for NDA submission in 2024, with topline results expected in 2Q 2024. Market expansion for PPD treatment is anticipated due to increased awareness. The FDA has accepted a proposal for NDA filing based on a single pivotal PK study.
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