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SALT LAKE CITY - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company with a market capitalization of approximately $17 million, has announced that its licensing partner, Verity Pharma, has submitted a New Drug Submission (NDS) in Canada for TLANDO®, an oral testosterone replacement therapy (TRT). TLANDO is already approved by the US Food and Drug Administration (FDA) and is notable for not requiring dose titration. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 15.6x.
TLANDO’s submission to Health Canada by Verity Pharma marks a significant step in expanding the drug’s availability beyond the United States. With over 700,000 TRT prescriptions written annually in Canada, and about half of these patients having private insurance coverage, the market potential for TLANDO is considerable. Currently, there is limited promotion for existing TRT options, which could allow TLANDO to capture a substantial market share if approved. InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets between $6.75 and $8.00 per share.
In January 2024, Lipocine and Verity Pharma entered an exclusive licensing agreement granting Verity Pharma commercial rights to TLANDO in North America. TLANDO leverages Lipocine’s proprietary Lip’ral drug delivery technology and is indicated for adult males with conditions related to testosterone deficiency.
Lipocine’s portfolio includes several other clinical development candidates targeting large market opportunities and unmet medical needs, such as treatments for postpartum depression, epilepsy, essential tremor, obesity management, and liver cirrhosis symptoms.
The information in this article is based on a press release statement from Lipocine Inc. The company’s forward-looking statements involve risks and uncertainties, including the potential for unsuccessful development efforts, insufficient capital, the inability to form strategic partnerships, and the possibility that the FDA may not approve proposed products.
In other recent news, Lipocine Inc. has entered into a licensing agreement with Aché Laboratórios Farmacêuticos S.A. to market its oral testosterone therapy, TLANDO, in Brazil. This partnership grants Aché exclusive rights to sell TLANDO in a market that has experienced a 34% compound annual growth rate from 2019 to 2023. TLANDO, approved by the US FDA for testosterone replacement therapy in adult males, will be the first oral testosterone treatment registered in Brazil. Lipocine has received an upfront payment from Aché, with potential for additional regulatory milestone payments and royalties on net sales. Aché will manage the regulatory submission and approval process for TLANDO in Brazil. Mahesh Patel, CEO of Lipocine, highlighted Aché’s commercial and regulatory capabilities as crucial for the successful introduction of TLANDO in Brazil. This development marks a significant step for Lipocine as it continues to expand its portfolio of drug candidates targeting large markets with unmet medical needs.
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