Welcome to our dedicated page for Lipella Pharmaceuticals news (Ticker: LIPO), a resource for investors and traders seeking the latest updates and insights on Lipella Pharmaceuticals stock.
Lipella Pharmaceuticals Inc (LIPO) is a clinical-stage biotechnology company pioneering advanced drug reformulations for conditions with significant unmet medical needs. Specializing in liposomal delivery technology, Lipella develops targeted therapies for complex disorders including Oral Lichen Planus and Hemorrhagic Cystitis.
This news hub provides investors and industry professionals with timely, comprehensive updates on Lipella's clinical progress, regulatory milestones, and strategic initiatives. Track developments across key areas including Phase 2 trial results, intellectual property updates, and partnership announcements.
Our curated news collection features verified press releases, clinical trial disclosures, and scientific presentations related to Lipella's pipeline candidates like LP-10 and LP-310. Stay informed about advancements in localized drug delivery systems and patent-protected innovations.
Bookmark this page for direct access to primary source materials and objective reporting on Lipella's research achievements. Regularly updated with official company communications, this resource supports informed analysis of the company's position within the competitive biopharmaceutical landscape.
Lipella Pharmaceuticals (Nasdaq: LIPO) has initiated a Phase 2a clinical trial for LP-310, enrolling the first patients to evaluate its efficacy in treating Oral Lichen Planus (OLP). This chronic inflammatory condition affects over 6 million Americans and currently lacks FDA-approved treatments. The multi-center, dose-ranging study is testing LP-310, a proprietary liposomal-tacrolimus oral rinse formulation derived from Lipella's lead candidate LP-10 for hemorrhagic cystitis.
The trial has commenced across multiple research sites nationwide, from Philadelphia to San Francisco. Lipella expects to conclude the trial by mid-2025, with top-line data anticipated by year-end 2024. LP-310 aims to address the underlying causes of OLP, potentially offering a transformative therapy that could alleviate symptoms and improve patient outcomes while minimizing systemic toxicity.
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the completion of its first Site Initiation Visit (SIV) for the Phase 2a trial of LP-310, targeting Oral Lichen Planus (OLP). The trial, starting in mid-2024, will involve 24 adult subjects across five U.S. sites. LP-310, a proprietary liposomal-tacrolimus oral rinse, will be tested for safety, tolerability, and efficacy at doses of 0.25 mg, 0.5 mg, and 1.0 mg. The study addresses the unmet need for an FDA-approved OLP treatment and is expected to conclude in mid-2025. Lipella's CEO and CMO expressed optimism about providing a potential treatment for the 6 million Americans suffering from OLP.
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the publication of an abstract at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. The abstract, titled “Intravesical Administration of Pembrolizumab for Bladder Tumor- A Potential Strategy to Minimize Drug Toxicity,” presents new preclinical data for LP-50, an intravesical formulation for treating non-muscle invasive bladder cancer (NMIBC).
The preclinical results indicate that LP-50 has the potential to increase efficacy while reducing systemic toxicity. Dr. Michael Chancellor, the Chief Medical Officer of Lipella, provided insights into these promising results. The ASCO annual meeting will take place from May 31 to June 4, 2024, in Chicago, IL, and online.
The American Cancer Society estimates there will be 83,190 new cases of bladder cancer diagnosed in the United States in 2024.
Lipella Pharmaceuticals (NASDAQ: LIPO) announced FDA guidance for its lead product, LP-10, in a Type-C meeting. LP-10, intended for moderate to severe hemorrhagic cystitis, will enter Phase 2b trials in the second half of 2024. The trial will include around 36 patients and will focus on objectives, safety, control group monitoring, dosing, efficacy endpoints, and sample size. Previous Phase 2a studies showed positive results with improved urinary symptoms in 13 patients. This FDA feedback allows Lipella to proceed confidently with their next trial phase, enhancing their value proposition.
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