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SALT LAKE CITY - Lipocine Inc. (NASDAQ: NASDAQ:LPCN), a biopharmaceutical company with a market capitalization of approximately $24 million, announced today that it will conduct a phase 3 safety and efficacy study for its oral drug candidate LPCN 1154, following revised regulatory guidance from the U.S. Food and Drug Administration (FDA). According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics. The study is a step toward a New Drug Application (NDA) submission for the treatment of postpartum depression (PPD (NASDAQ:PPD)).
The FDA’s updated guidance specified that in addition to the pharmacokinetic (PK) bridge data already completed, a targeted study on the efficacy and safety of LPCN 1154 is necessary for the 505(b)(2) NDA submission pathway. The company maintains a strong financial position, with InvestingPro data showing a healthy current ratio of 13x and more cash than debt on its balance sheet.
LPCN 1154, an oral formulation of brexanolone, is designed to offer rapid relief for PPD. Brexanolone is a neuroactive steroid that modulates the GABAA receptor. The company believes that this drug could provide a significant benefit to patients with severe PPD and those at an acutely elevated risk of suicide, while also being safe for breastfed infants.
Mahesh Patel, CEO of Lipocine, stated that the upcoming study will not only help in generating data for product labeling but also in securing clinical investigation exclusivity for the 48-hour oral treatment. He further noted the study’s potential to explore LPCN 1154’s use in treating anxiety disorders, marking an additional commercial opportunity given the high unmet need.
Postpartum depression is a major depressive disorder that occurs during pregnancy or within four weeks of delivery, with symptoms that can last up to 12 months post-childbirth. Despite the availability of traditional antidepressants, there remains a significant need for treatments that can offer rapid onset of action and fewer side effects.
Lipocine is leveraging its proprietary technology platform to develop oral delivery therapeutics, with a pipeline that includes drug candidates for epilepsy, essential tremor, obesity management, and liver cirrhosis, among others.
The company’s statement is based on a press release and contains forward-looking statements regarding the development of LPCN 1154 and its potential benefits. However, these statements are subject to various risks, including the success of clinical trials and regulatory approval processes. InvestingPro data indicates analysts expect revenue growth of over 460% this year, though the company is currently burning through cash at a notable rate. For deeper insights into Lipocine’s financial health and growth prospects, investors can access additional ProTips and detailed metrics through InvestingPro.
In other recent news, Lipocine Inc., a biopharmaceutical company, has announced a significant development. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s drug candidate, LPCN 1148. This drug is aimed at treating sarcopenia in patients with decompensated cirrhosis, a severe liver condition. The Fast Track program expedites the development and review of drugs for serious conditions with unmet medical needs. LPCN 1148, an oral prodrug of bioidentical testosterone, demonstrated positive results in a Phase 2 study, improving muscle mass and associated clinical outcomes in this patient group. Currently, there are no FDA-approved treatments specifically for sarcopenia in these patients, making this development particularly noteworthy. Lipocine’s President and CEO, Dr. Mahesh Patel, has expressed optimism regarding the potential of LPCN 1148 to address this unmet medical need.
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