Earnings summaries and quarterly performance for LIPELLA PHARMACEUTICALS.
Research analysts covering LIPELLA PHARMACEUTICALS.
Recent press releases and 8-K filings for LIPO.
Lipella Pharmaceuticals Highlights LP-10 Phase 2 Results and Market Potential
LIPO
New Projects/Investments
- Lipella Pharmaceuticals Inc. leverages proprietary liposomal formulations for targeted delivery to mucosal tissue and utilizes the 505(b)(2) regulatory pathway to accelerate clinical development.
- Their lead asset, LP-10 oral rinse, a tacrolimus formulation, is being developed for Oral Lichen Planus (OLP), a T-cell-mediated autoimmune disorder affecting up to 2% of U.S. adults with no approved therapies.
- A Phase 2 clinical trial for LP-10 in OLP patients demonstrated positive safety and efficacy signals, including significant improvements in patient-reported outcomes and minimal systemic absorption of tacrolimus, with no serious adverse events.
- LP-10 for OLP is projected to achieve $750 million in peak sales by 2035, with a $350 million risk-adjusted net present value, targeting an addressable U.S. patient population of 1.2 million and an anticipated monthly wholesale acquisition cost of $1,000.
- The company reported $1 million to $2 million in cash in its last quarterly statement and estimates needing approximately $20 million to bring LP-10 oral rinse to commercialization.
Sep 18, 2025, 4:30 PM
Lipella Pharmaceuticals Announces Positive Phase 2a Results for LP-10 in Oral Lichen Planus
LIPO
Product Launch
New Projects/Investments
Delisting/Listing Issues
- Lipella Pharmaceuticals Inc. announced positive final results from its Phase 2a study of LP-10 in Oral Lichen Planus (OLP) on September 18, 2025, successfully meeting its primary safety endpoint and achieving statistically significant improvements across all efficacy measures.
- The study reported no serious adverse events among the 27 patients who completed treatment, with minimal systemic exposure of the drug.
- Based on these results, the company is preparing to initiate a pivotal Phase 2b study for LP-10, which has the potential to become the first FDA-approved therapy for OLP, a condition affecting an estimated 6 million Americans with no current approved treatments.
- The company's common stock was suspended from Nasdaq on June 20, 2025, and is currently quoted on the OTCID Market under the symbol "LIPO".
Sep 18, 2025, 12:01 PM
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