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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 announcement that it has dosed the first patient in its Phase 3 trial of LPCN 1154 for postpartum depression (PPD (NASDAQ:PPD)). According to InvestingPro data, analysts maintain a Strong Buy consensus with price targets ranging from $6.75 to $8.00, suggesting significant upside potential. The stock currently appears undervalued based on InvestingPro’s Fair Value analysis.
The Phase 3 trial, announced on June 26, is designed as a randomized, blinded study that will enroll 80 women aged 15 years and older who have been diagnosed with severe PPD. Patients in the experimental group will take oral LPCN 1154 tablets at home for 48 hours, while those in the comparator arm will receive placebo tablets for the same duration. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 15.64, providing adequate resources for trial completion.
The study’s primary efficacy endpoint is the change from baseline to Hour 60 in the Hamilton Depression Rating Scale (HAM-D), a clinical measure of depression severity with scores ranging from 0 to 52, where higher scores indicate more severe depression. The trial size has been powered based on treatment effects observed with FDA-approved injectable brexanolone.
LPCN 1154 is an oral formulation of brexanolone designed for rapid relief of PPD and has demonstrated bioequivalence with intravenous brexanolone in clinical oral pharmacokinetic studies. This oral delivery method could potentially offer advantages over the current injectable treatment option.
Lipocine’s management expects to report topline results from the trial in the second quarter of 2026, with H.C. Wainwright noting that positive results could support a 505(b)(2) New Drug Application submission for LPCN 1154 in PPD by mid-2026. The company holds more cash than debt on its balance sheet, though InvestingPro data indicates a rapid cash burn rate. Subscribers can access 5 additional ProTips and comprehensive financial metrics to better evaluate the company’s investment potential.
In other recent news, Lipocine Inc. has dosed the first patient in a Phase 3 clinical trial of its oral postpartum depression treatment, LPCN 1154. The trial aims to evaluate the drug’s efficacy in women with severe postpartum depression, with results expected in mid-2026. Meanwhile, Lipocine’s licensing partner, Verity Pharma, has filed for Canadian approval of TLANDO®, an oral testosterone replacement therapy, which is already approved in the United States. This move could expand TLANDO’s market presence, given the significant number of TRT prescriptions in Canada. Additionally, 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. Aché will handle the regulatory submission and approval process in Brazil, and Lipocine could receive milestone payments and royalties upon approval. These developments reflect Lipocine’s ongoing efforts to expand its market reach and address unmet medical needs with its drug portfolio.
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