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Investing.com - H.C. Wainwright has reiterated its Buy rating and $8.00 price target on Lipocine Inc (NASDAQ:LPCN) following the company’s second-quarter financial results and clinical progress. The stock, currently trading at $3.04, appears undervalued according to InvestingPro analysis, with analyst targets ranging from $6.75 to $8.00.
Lipocine reported total revenue of $623,000 for the second quarter of 2025, which included $123,000 in royalties from TLANDO sales and $500,000 in license revenue. The company posted a net loss of $2.2 million, or ($0.41) per share, matching analyst expectations. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 12.71, though it’s currently experiencing rapid cash burn. Get access to 5 more exclusive ProTips and detailed financial metrics with InvestingPro.
The biopharmaceutical company, with a market capitalization of $16.26 million, is currently treating patients in its Phase 3 trial of LPCN 1154 for postpartum depression (PPD (NASDAQ:PPD)). According to the protocol, the randomized, blinded study aims to enroll 80 women aged 15 years and older diagnosed with severe PPD.
The trial design has patients in the experimental arm taking oral LPCN 1154 tablets at home for 48 hours, while those in the comparator arm receive placebo tablets for the same duration. The primary efficacy endpoint measures change from baseline to Hour 60 in the Hamilton Depression Rating Scale (HAM-D).
Lipocine management expects to hold its first Data and Safety Monitoring Board meeting in the second half of 2025, with topline results anticipated in the second quarter of 2026, followed by a 505(b)(2) new drug application submission in mid-2026.
In other recent news, Lipocine Inc. has made significant strides in its clinical and regulatory endeavors. The company has dosed the first patient in its pivotal Phase 3 clinical trial for LPCN 1154, an investigational oral treatment for postpartum depression (PPD). This trial, which involves a randomized and blinded study, will include 80 women diagnosed with severe PPD, and the treatment will be administered over a 48-hour period. H.C. Wainwright has reiterated its Buy rating for Lipocine, maintaining a price target of $8.00, following the commencement of this Phase 3 trial. The research firm emphasized the potential of Lipocine’s treatment to address the limitations of current PPD therapies.
Additionally, Lipocine’s licensing partner, Verity Pharma, has submitted a New Drug Submission in Canada for TLANDO®, an oral testosterone replacement therapy. TLANDO is already approved in the United States and does not require dose titration, which could enhance its appeal in the Canadian market. The submission represents a key step in expanding the availability of TLANDO beyond the U.S., with the potential to capture a significant market share in Canada. These developments mark important progress in Lipocine’s efforts to advance its therapeutic offerings.
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