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SALT LAKE CITY - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company with a market capitalization of $18.3 million and impressive revenue growth of 493% over the last twelve months, has announced a licensing agreement with Brazilian pharmaceutical company Aché Laboratórios Farmacêuticos S.A. to market its oral testosterone therapy, TLANDO, in Brazil. The agreement grants Aché exclusive rights to sell the product in a market that has seen a significant 34% compound annual growth rate from 2019 to 2023. According to InvestingPro analysis, Lipocine maintains a strong financial position with more cash than debt and a healthy current ratio of 14.75, providing stability for international expansion.
With no oral testosterone treatments currently registered in Brazil, TLANDO’s entry into the market is poised to meet an unmet medical need. TLANDO, which is approved by the US FDA for testosterone replacement therapy in adult males, utilizes Lipocine’s proprietary Lip’ral drug delivery technology platform.
Mahesh Patel, CEO of Lipocine, expressed optimism about the partnership, citing Aché’s commercial and regulatory capabilities as key to introducing TLANDO to patients in Brazil. Lipocine has received an upfront payment under the agreement and could receive additional regulatory milestone payments and royalties on net sales. InvestingPro data suggests the company is currently undervalued, with analysts setting a consensus target price significantly above current levels. For more insights on undervalued opportunities, visit the Most Undervalued Stocks list. Aché will handle the regulatory submission and approval process in Brazil.
Achê is a prominent player in the Brazilian pharmaceutical scene, with a nearly 60-year history and a strong presence in the prescription, generic, and over-the-counter markets. The company’s products are distributed in over 20 countries, including across Latin America, Africa, Asia, and Europe.
Lipocine continues to develop a range of drug candidates targeting large markets with significant medical needs, including treatments for postpartum depression, epilepsy, essential tremor, and obesity management, among others. Subscribers to InvestingPro can access additional financial health metrics and 8 more exclusive ProTips to better evaluate Lipocine’s growth potential and investment outlook.
This partnership announcement is based on a press release statement and does not constitute an endorsement of Lipocine Inc. or its products. The information provided is intended for general informational purposes only and does not involve any recommendation or endorsement by the reporting entity.
In other recent news, Lipocine Inc. announced plans to conduct a phase 3 safety and efficacy study for its oral drug candidate, LPCN 1154, aimed at treating postpartum depression. This decision follows revised guidance from the U.S. Food and Drug Administration, which requires a targeted study on the efficacy and safety of LPCN 1154 for the 505(b)(2) New Drug Application submission pathway. The company believes LPCN 1154, an oral formulation of brexanolone, could offer rapid relief for postpartum depression while being safe for breastfed infants. Mahesh Patel, CEO of Lipocine, highlighted the study’s potential not only for generating data for product labeling but also for exploring the drug’s use in treating anxiety disorders. Lipocine is utilizing its proprietary technology platform to develop oral delivery therapeutics, with a pipeline that includes drug candidates for various conditions such as epilepsy and obesity management. The company’s statement notes that the development of LPCN 1154 and its potential benefits are subject to risks, including the success of clinical trials and regulatory approval processes.
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