Lipella Pharmaceuticals Inc Stock Price, News & Analysis

Lipella Pharmaceuticals (NASDAQ: LIPO) will present Phase 2a trial data for LP-310 (liposomal tacrolimus oral rinse) in treating Oral Lichen Planus (OLP) at the 2025 AAOM/EAOM International Meeting. The 0.50 mg dose showed statistically significant improvements across multiple endpoints, including:

• Investigator Global Assessment improved from 3.42 to 1.71 (p=0.007)
• REU Score reduced from 26.91 to 11.88 (p=0.003)
• OLPSSM dropped from 14.92 to 4.88 (p=0.003)
• Pain NRS improved from 6.42 to 2.25 (p=0.003)

The treatment was well-tolerated with no serious adverse events, no discontinuations, and no detectable systemic tacrolimus levels. Final topline data from the fully enrolled trial is expected in Q2 2025.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced that its abstract on LP-10 for treating Oral Lichen Planus (OLP) will be presented at the 2025 joint international meeting of AAOM and EAOM in Las Vegas, May 14-17. The presentation, titled 'Liposomal Tacrolimus (LP-10) Oral Rinse for the Treatment of Oral Lichen Planus: Topline Analysis of a Phase 2a Multicenter Dose-Ranging Trial,' will be delivered by Dr. Alessandro Villa of Miami Cancer Institute.

The study evaluates LP-10, a liposomal formulation of tacrolimus, in patients with symptomatic OLP. Topline results demonstrate clinically meaningful improvements after four weeks of treatment, with statistically significant improvements across clinical measures and visible reductions in inflammation. The oral rinse showed good tolerability and resolution of ulcerative lesions in some patients. Final topline results from the fully enrolled trial are expected in Q2 2025.

Lipella Pharmaceuticals (NASDAQ: LIPO) announced positive topline results from the second cohort (0.50 mg) of its Phase 2a trial for LP-310, a liposomal-tacrolimus oral rinse for oral lichen planus (OLP) treatment. The trial demonstrated statistically significant improvements across multiple endpoints:

Key findings include:

• Investigator Global Assessment improved from 3.42 to 1.71 at week 4 (p=0.007)
• REU Score reduced from 26.91 to 11.88 at week 4 (p=0.003)
• Pain rating decreased from 6.42 to 2.25 at week 4 (p=0.003)

The treatment showed strong safety profile with no treatment-related SAEs and complete patient adherence. The trial is now fully enrolled across all three dose cohorts, with final topline data from the 1.0 mg cohort expected in Q2 2025. The company plans to submit an IND application for Phase 2b trial in late 2025.

Lipella Pharmaceuticals (Nasdaq: LIPO) has completed enrollment in its Phase 2a multicenter, dose-ranging trial for LP-310, a liposomal tacrolimus oral rinse targeting oral lichen planus (OLP). The trial enrolled participants across three dose cohorts (0.25 mg, 0.50 mg, and 1.0 mg of tacrolimus) at seven U.S. study sites.

The company reports encouraging safety and efficacy signals from the first two dose cohorts, noting clinically meaningful reductions in pain, ulceration, and inflammation. Topline results from the final cohort (1.0 mg) are expected in Q2 2025, representing the most comprehensive clinical dataset for LP-310 to date. LP-310 aims to provide a non-steroidal, locally delivered treatment option for OLP, a condition currently lacking FDA-approved therapies.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced that Co-Founder and Chief Medical Officer Dr. Michael Chancellor is featured in the latest episode of The Pharmaverse Podcast. The episode, titled 'From Medicine to Biotech Innovation,' explores Dr. Chancellor's 40-year career transition from clinical medicine to biotech leadership.

During the podcast, Dr. Chancellor discusses Lipella's development, including challenges in clinical trials, fundraising, and the IPO process. The company recently reported positive Phase 2a results for LP-310 in February 2025, showing clinically meaningful reductions in pain, ulceration, and inflammation for patients with Oral Lichen Planus.

Lipella Pharmaceuticals (NASDAQ: LIPO) announced positive topline results from its Phase 2a trial of LP-310, a liposomal-tacrolimus oral rinse for treating oral lichen planus (OLP). The trial demonstrated statistically significant improvements across multiple endpoints with a strong safety profile.

The study's first cohort, involving eight participants receiving 0.25 mg twice-daily doses, showed significant improvements in key metrics including:

• Investigator Global Assessment improved from 3.50 to 1.75 at week 4
• REU Score reduced from 27.75 to 12.69 at week 4
• Pain scores decreased from 6.63 to 2.38 at week 4

The trial has progressed to a higher dose cohort of 0.5 mg/10 mL across seven U.S. sites, with completion expected by mid-2025. The company plans to submit a Phase 2b trial application and request Breakthrough Therapy designation in the second half of 2025.

Lipella Pharmaceuticals (Nasdaq: LIPO) has received FDA approval for an Expanded Access Program (EAP) for LP-310, an oral rinse treatment for oral lichen planus (OLP). LP-310 is designed to provide targeted relief for OLP, a chronic inflammatory condition affecting mouth mucous membranes that impacts approximately 6 million Americans.

The EAP approval allows patients with serious or life-threatening conditions to access LP-310 outside of clinical trials before FDA approval. This is particularly significant as there are currently no FDA-approved therapies for OLP, which causes burning pain, white patches, swollen tissue, and open sores.

The company views this approval as a key milestone in addressing the unmet medical need in OLP treatment, supporting their ongoing clinical development efforts.

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.