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PITTSBURGH - Lipella Pharmaceuticals Inc. (NASDAQ:LIPO), a biotech firm specializing in novel therapies for medical conditions lacking adequate treatments, has received FDA approval for an Expanded Access Program (EAP) for its oral rinse product, LP-310. The EAP will provide patients with oral lichen planus (OLP), a chronic inflammatory condition of the mouth’s mucous membranes, access to LP-310 outside of clinical trials. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt and a current ratio of 2.97x, providing financial flexibility for its clinical development programs.
OLP affects roughly 6 million Americans, presenting with symptoms such as burning pain, white patches, swollen tissue, and open sores. To date, no FDA-approved therapies exist for this condition, underscoring the significance of the EAP for those suffering from OLP. While the market opportunity is substantial, InvestingPro analysis indicates the company is currently in its development phase, with analysts anticipating a sales decline in the current year. InvestingPro subscribers have access to 8 additional key insights about LIPO’s financial health and market position.
LP-310 is an oral rinse formulation of tacrolimus that targets inflammation and immune response in OLP patients. By delivering localized therapy, LP-310 aims to minimize systemic exposure and the associated risks of long-term steroid use. Currently, LP-310 is undergoing a Phase 2a multicenter, dose-ranging clinical trial to assess its safety, tolerability, and efficacy. The trial is active across seven U.S. sites, with participant recruitment in progress.
Michael Chancellor, Co-Founder and Chief Medical (TASE:PMCN) Officer of Lipella Pharmaceuticals, stated, "Receiving FDA approval for expanded use of LP-310 represents a key milestone in our mission to address the significant unmet need in oral lichen planus treatment." He expressed the company’s commitment to advancing LP-310 as a potential solution for patients.
The FDA’s nod for the expanded use of LP-310 underscores its potential as a new therapeutic option for OLP and supports ongoing clinical development efforts. Lipella Pharmaceuticals continues to focus on repurposing active agents in existing generic drugs to address diseases with significant unmet needs.
This news is based on a press release statement and reflects the current status of LP-310’s development and regulatory progress. The company’s stock has experienced significant volatility, declining 46.87% over the past six months, though InvestingPro’s Fair Value analysis suggests the stock may be undervalued at current levels. With the next earnings report due on February 26, 2025, investors seeking detailed financial analysis and real-time updates can access comprehensive metrics and expert insights through InvestingPro.
In other recent news, Lipella Pharmaceuticals Inc. has been facing a series of significant developments. The company received a notice from the Nasdaq Hearings Panel regarding potential delisting due to non-compliance with the stock market’s listing rules. Lipella has been granted an extension to meet Nasdaq’s Minimum Stockholders’ Equity Requirement and must provide a public disclosure by April 14, 2025, outlining its fundraising plans and strategies to maintain compliance.
In addition, Lipella recently failed to reach a quorum at its special meeting of stockholders, leading to the meeting’s cancellation. This event followed an earlier adjournment due to the same issue, underscoring challenges in gathering sufficient shareholder participation for crucial company decisions.
The company also executed a one-for-eight reverse stock split of its common stock, following authorization from its stockholders. This strategic move, which affects the total number of outstanding shares, options, and warrants proportionally, is aimed at adjusting Lipella’s share structure.
These are recent developments that investors and stakeholders should monitor closely. However, it’s important to note that the company’s ability to meet obligations and maintain compliance with Nasdaq’s listing standards remains uncertain.
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