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Investing.com - H.C. Wainwright has reiterated a Buy rating and $8.00 price target on Lipocine Inc (NASDAQ:LPCN) following the company’s recent R&D event focused on postpartum depression (PPD (NASDAQ:PPD)) treatment.
The research firm highlighted that perinatal depression remains under-diagnosed and undertreated, potentially leading to adverse outcomes for both mothers and children. Current standard treatments using serotonergic antidepressants show limitations including low response rates, delayed improvement of 6-8 weeks, and side effects reported by 86% of patients. InvestingPro analysis shows Lipocine maintains strong financial flexibility with a healthy current ratio of 15.64 and more cash than debt on its balance sheet.
H.C. Wainwright noted that neuroactive steroids represent an emerging treatment option, with IV brexanolone approved in 2019 and zuranolone in 2023, offering faster onset of action and shorter treatment courses compared to traditional antidepressants.
The firm specifically pointed to Lipocine’s LPCN 1154, an oral formulation of brexanolone, as potentially improving upon existing treatments with onset of action in hours, treatment duration of just 48 hours, remission rates up to 61% at Day 3, and no adverse events of excessive sedation or loss of consciousness in completed clinical trials.
With PPD affecting approximately 600,000 women annually in the U.S., and both the American Academy of Pediatrics and American College of Obstetricians and Gynecologists recommending screening and consideration of brexanolone or zuranolone treatments, H.C. Wainwright believes LPCN 1154 could become a "best-in-class neuroactive steroid" for PPD treatment. With a market cap of just $17.76 million and analysts expecting profitability this year, investors seeking deeper insights can access additional financial metrics and 7 more exclusive InvestingPro Tips at InvestingPro.
In other recent news, Lipocine Inc. has initiated a pivotal Phase 3 clinical trial for LPCN 1154, an investigational oral formulation aimed at treating postpartum depression (PPD). The trial, which has already dosed its first patient, will compare LPCN 1154 against a placebo in a randomized, blinded study involving women aged 15 and older. The company aims to use the trial data to support a New Drug Application submission by mid-2026, with top-line results expected in the second quarter of that year. Additionally, Lipocine’s licensing partner, Verity Pharma, has filed a New Drug Submission in Canada for TLANDO®, an oral testosterone replacement therapy. This submission marks a move to expand TLANDO’s availability beyond the United States, where it is already FDA-approved. In another development, Lipocine has entered into a licensing agreement with Aché Laboratórios Farmacêuticos S.A. to market TLANDO in Brazil, a market with no current oral testosterone treatments. This agreement includes potential milestone payments and royalties on net sales. Furthermore, H.C. Wainwright has maintained its Buy rating on Lipocine, emphasizing the potential of LPCN 1154 to address unmet medical needs in PPD treatment.
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