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.
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the publication of a peer-reviewed paper in CUREUS focusing on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs). The paper discusses the company's investigational therapy LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) designed for localized therapeutic effects while minimizing systemic exposure. LP-310 is currently in a Phase 2a multicenter clinical trial evaluating safety, tolerability, and efficacy in adult OLP patients. The publication explores TCIs as alternatives to traditional corticosteroid treatments, aiming to reduce undesirable side effects associated with long-term steroid use.
Lipella Pharmaceuticals has completed dosing for the first cohort in its Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse for Oral Lichen Planus (OLP). Eight participants received a 0.25 mg dose, showing promising initial results with no product-related serious adverse events. Blood tacrolimus levels were minimal or undetectable, indicating localized therapeutic effects. The trial has advanced to testing a higher 0.5 mg dose. The study spans seven U.S. sites, with top-line data expected by year-end 2024 and trial completion by mid-2025. OLP affects approximately 6 million Americans and currently lacks FDA-approved therapies.
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the issuance of U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform. The patent, titled 'Delivery of Agents Using Metastable Liposomes,' extends market exclusivity for the company's lead clinical assets, LP-10 and LP-310, currently in Phase 2 trials. LP-10 is a liposomal formulation of tacrolimus for hemorrhagic cystitis, while LP-310 is an oral rinse for oral lichen planus. The company holds additional patents in the United States, Australia, and Canada, providing exclusivity until 2035.
Lipella Pharmaceuticals (Nasdaq: LIPO) announced a 1-for-8 reverse stock split effective November 7, 2024, with split-adjusted trading beginning November 8, 2024. The measure aims to comply with Nasdaq Capital Market's minimum bid price requirement. The split was approved by stockholders on September 10, 2024. The company's authorized shares will remain at 200,000,000, with a par value of $0.0001 per share. Nevada Agency and Transfer Company will serve as the exchange agent, with stockholders receiving transition information directly.
Lipella Pharmaceuticals (Nasdaq: LIPO), a clinical-stage biotechnology company, has announced its participation in the 2024 Spartan Capital Investor Conference. CEO Jonathan Kaufman, PhD, will deliver a presentation on November 4th, 2024, at 9:25 am EST at the Pierre Hotel in New York. The company, which focuses on addressing serious diseases with significant unmet needs, will also offer one-on-one meetings with registered conference investors.
Lipella Pharmaceuticals (Nasdaq: LIPO) has received a notice of allowance from the USPTO for its proprietary liposomal drug delivery platform. The patent application, titled 'Delivery of Agents Using Metastable Liposomes,' covers key innovations in Lipella's technology for delivering therapeutic agents via liposome-based vehicles.
This breakthrough enables precise, targeted delivery, improving safety and efficacy across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy. The patent provides broad IP protection for Lipella's drug delivery platform, which optimizes delivery to epithelial tissues. It extends market exclusivity for two lead clinical assets currently in Phase 2 trials.
Dr. Michael Chancellor, CMO of Lipella, highlighted the significance of this milestone in advancing therapies for conditions such as hemorrhagic cystitis and oral lichen planus. The company's liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing systemic side effects.
Lipella Pharmaceuticals (Nasdaq: LIPO), a clinical-stage biotechnology company, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Jonathan Kaufman, PhD, will be presenting at the event on Thursday, October 17th, 2024, at 10:30am.
The summit is scheduled to take place from October 15-17, 2024. Interested parties can access the webcast of Lipella's presentation at https://m-vest.com/events/healthcare-10152024. Additionally, Dr. Kaufman will be available for one-on-one meetings with registered investors attending the conference.
Lipella Pharmaceuticals focuses on developing treatments for serious diseases with significant unmet needs, positioning itself as a key player in the biotechnology sector.
Lipella Pharmaceuticals (Nasdaq: LIPO) has reported encouraging early tolerability results in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP). Three participants have completed the four-week treatment with the oral rinse, showing good tolerability and no unpleasant taste. The multi-center study is evaluating the safety, tolerability, and efficacy of LP-310 at various doses.
LP-310 is a proprietary liposomal-tacrolimus formulation targeting the underlying causes of OLP. It aims to provide a more effective alternative to current palliative treatments by delivering concentrated therapeutic effects directly in the oral cavity while minimizing systemic toxicity. Notably, LP-310 is the only topical treatment in development for OLP, a condition with no FDA-approved pharmacotherapies.
The trial is being conducted at five active sites across the U.S. and is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. These early results suggest LP-310's potential as a breakthrough treatment for OLP, a condition that significantly impacts patients' quality of life.
Lipella Pharmaceuticals (Nasdaq: LIPO) is set to participate in H.C. Wainwright's 26th Annual Global Investment Conference in New York City from September 9-11, 2024. The company will deliver a virtual presentation and offer one-on-one meetings for qualified investors at the Lotte New York Palace Hotel.
Lipella has two lead drug candidates in IND-approved phase 2 clinical trials for rare diseases, using the 505(b)(2) pathway:
- LP-310: A liposomal-tacrolimus oral rinse for oral lichen planus (OLP), with topline data expected by year-end 2024.
- LP-10: Liposomal tacrolimus for hemorrhagic cystitis (HC), with a phase 2b trial anticipated to start in the first half of 2025.
Both treatments target conditions with or no current therapeutic options in development, positioning Lipella as a potential leader in these rare disease markets.
Lipella Pharmaceuticals (NASDAQ: LIPO) has launched an Oral Lichen Planus (OLP) Patient Registry to advance research and treatment development for this chronic inflammatory disease affecting approximately 6 million Americans. OLP, which impacts the mouth's mucous membranes, currently has no FDA-approved therapies.
The company is also conducting an investigational study of LP-310, an oral rinse derived from their lead candidate LP-10. LP-310 has received FDA approval for clinical evaluation in treating OLP. This initiative aligns with Lipella's mission to improve treatment approaches for OLP, a condition characterized by burning pain, white patches, swollen tissue, and open sores.
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