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Lipella Pharmaceuticals Inc. - $LIPO STOCK NEWS

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. (Nasdaq: LIPO) is a clinical-stage biotechnology company focused on developing innovative drugs by reformulating active agents in existing generic drugs for new therapeutic applications. Based in Pittsburgh, PA, Lipella addresses serious diseases with significant unmet medical needs.

Currently, the company's product pipeline includes promising candidates like LP-10, LP-310, and LP-410. LP-310 is in the spotlight, having recently received Orphan Drug Designation from the U.S. FDA for the treatment of oral Graft-versus-Host Disease (GvHD). This designation provides the company with several incentives, including tax credits for clinical trials and market exclusivity upon approval.

LP-310, Lipella’s proprietary liposomal tacrolimus formulation, is designed as an oral rinse to treat inflammatory diseases of the oral cavity such as oral lichen planus and oral GvHD. The company recently gained FDA clearance for a Phase 2a clinical trial to assess LP-310’s safety and efficacy in treating symptomatic oral lichen planus.

The company's CEO, Dr. Jonathan Kaufman, has emphasized the importance of these designations and their role in de-risking their clinical research programs. Dr. Michael Chancellor, the Chief Medical Officer, has highlighted the significant impact of oral GvHD on cancer survivors' quality of life, noting that the disease affects roughly 30,000 Americans.

LP-10, another of Lipella's leading candidates, is an intravesical liposomal formulation of tacrolimus for treating moderate to severe hemorrhagic cystitis. This chronic condition involves significant urinary blood loss, often linked to cancer therapies, and currently has no FDA-approved treatments. Lipella plans to initiate a Phase 2b clinical trial for LP-10 in the second half of 2024.

LP-50 is an intravesical formulation aimed at treating non-muscle invasive bladder cancer (NMIBC). The company's recent preclinical results showcased LP-50's potential to increase efficacy while minimizing systemic toxicity, demonstrating promising outcomes in induced murine NMIBC models.

Lipella Pharmaceuticals completed its initial public offering in December 2022 and continues to focus on developing treatments for diseases with significant unmet needs. For more information, visit their website at www.lipella.com.

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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.

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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.

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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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Lipella Pharmaceuticals, a clinical-stage biotechnology company, has expanded its Scientific Advisory Board to include oncology expertise. The new committee members, Dr. Jason Hafron and Dr. Pradeep Tyagi, bring valuable clinical and translational research experience in cancer treatment, specifically urologic oncology. The company aims to advance its discovery efforts in treating non-muscle invasive bladder cancer (NMIBC) with the help of these experts.
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Lipella Pharmaceuticals Inc. announces acceptance of abstract for ASCO 2024 meeting, presenting novel treatment strategy for bladder cancer. The abstract focuses on intravesical administration of pembrolizumab to minimize toxicity, highlighting preclinical data efficacy in mice.
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Lipella Pharmaceuticals Inc. (LIPO) receives FDA Type C meeting to discuss Phase-2b trial design for LP-10 in treating hemorrhagic cystitis. The potential treatment targets moderate to severe cases caused by cancer treatments. Dr. Michael Chancellor, Lipella's Chief Medical Officer, expresses eagerness for advancing the program. Lipella successfully completed a Phase-2a trial showing safety and potential efficacy. The upcoming Phase-2b trial aims to enroll 36 subjects in a double-blind, placebo-controlled study focusing on reducing gross hematuria episodes.
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Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) receives FDA approval for clinical testing of LP-410 in treating oral Graft-Versus-Host Disease, with trials expected to begin in Q2 2024. This marks a significant milestone for the company in addressing unmet medical needs.
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Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) announces Chief Medical Officer Dr. Michael Chancellor's presentation at the PropThink Digital Investor Conference on February 23, 2024, discussing hemorrhagic cystitis and the lead candidate LP-10. The presentation will cover bladder cancer, lasting side effects, potential therapies, tacrolimus treatment, and Lipella's Phase 2b clinical trial for HC.
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Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has been granted two orphan drug designations by the FDA. The company has achieved significant milestones over the past year, including successful clinical program completion for LP-10 and FDA approval for its IND application for a Phase 2a multicenter trial of an oral rinse formulation of LP-310. Lipella has also secured central IRB approval and orphan drug designation for LP-310 for the treatment of oral GVHD with tacrolimus.
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Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has been granted 'Orphan Drug Designation' from the U.S. FDA for its LP-310 drug candidate, aimed at treating oral Graft-versus-Host Disease (GvHD) and other inflammatory diseases of the oral cavity. The FDA's designation provides incentives and potential market exclusivity for the drug.
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FAQ

What is Lipella Pharmaceuticals Inc.?

Lipella Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing innovative drugs by reformulating existing generic drugs for new therapeutic applications.

What does Orphan Drug Designation mean for Lipella?

Orphan Drug Designation from the FDA provides incentives like tax credits for clinical trials and market exclusivity for drugs intended to treat rare diseases affecting fewer than 200,000 people in the U.S.

What is LP-310?

LP-310 is Lipella's proprietary liposomal tacrolimus oral rinse formulation, intended for the treatment of oral inflammatory diseases such as oral lichen planus and oral GvHD.

What conditions does LP-10 target?

LP-10 targets moderate to severe hemorrhagic cystitis, a chronic condition involving significant urinary blood loss often associated with cancer therapies.

What is the focus of LP-50?

LP-50 is focused on treating non-muscle invasive bladder cancer (NMIBC) with an intravesical formulation designed to increase efficacy and minimize systemic toxicity.

When did Lipella Pharmaceuticals go public?

Lipella Pharmaceuticals completed its initial public offering in December 2022.

What is the significance of Orphan Drug Designation for Lipella's products?

This designation helps the company benefit from tax credits for clinical trials, exemption from user fees, and potential market exclusivity, which can accelerate the development and approval of their products.

What is Graft-versus-Host Disease (GvHD)?

GvHD occurs when donor bone marrow or stem cells attack the recipient’s body tissues following treatment for hematological cancers, affecting various organs including the mouth, skin, liver, and gastrointestinal tract.

What clinical trials are currently underway for Lipella?

Lipella is undertaking a Phase 2a clinical trial for LP-310 in treating oral lichen planus and plans to initiate a Phase 2b trial for LP-10 in treating hemorrhagic cystitis.

How can I learn more about Lipella Pharmaceuticals?

For more information, visit Lipella Pharmaceuticals' website at www.lipella.com.

Lipella Pharmaceuticals Inc.

Nasdaq:LIPO

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Research and Development in Biotechnology
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