Lipella Pharmaceuticals Inc Stock Price, News & Analysis

Lipella Pharmaceuticals (Nasdaq: LIPO) announced a manufacturing collaboration with Cook MyoSite to support its drug candidate LP-10, aimed at treating hemorrhagic cystitis. LP-10 has received Orphan Drug Designation from the FDA and recently completed a Phase 2a clinical trial with positive results. The partnership is expected to streamline the Chemistry, Manufacturing, and Control (CMC) documentation process, crucial for regulatory approval. Dr. Michael Chancellor emphasized the importance of Cook MyoSite's expertise in GMP manufacturing for expediting clinical supplies for LP-10. The collaboration aims to address the significant unmet medical need for effective treatments for hemorrhagic cystitis.

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) announced it has successfully dosed the first patient in a human clinical trial for a novel bladder MRI contrast agent. This trial is supported by a $1.35 million Phase II Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases, awarded in 2022. The proprietary ICE-MRI technology aims to improve the diagnosis of interstitial cystitis/bladder pain syndrome and bladder tumors by accurately measuring bladder permeability. The trial represents an important milestone in developing objective diagnostic tools for urological conditions.

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) completed its Phase 2a clinical trial for LP-10, a treatment for moderate to severe refractory hemorrhagic cystitis, showing no serious adverse events and improved urinary symptoms. The company reported a year-end cash balance of over $5 million, ensuring operational capacity into 2024. In 2022, Lipella successfully executed its Initial Public Offering and appointed Douglas Johnston as CFO. The top line results will be presented at the American Urological Association Annual Meeting on April 30, 2023. Future plans include discussions with the FDA regarding regulatory approval and the development of LP-310 for oral lichen planus.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced the successful completion of a Phase 2A clinical trial for its drug candidate LP-10, targeting hemorrhagic cystitis. Conducted by Dr. Jason Hafron, the trial involved 13 subjects who showed tolerable responses to LP-10 intravesical instillations. Key results included reduced hematuria and improved urinary symptoms, with a complete response in three subjects. LP-10 has received Orphan Drug Designation from the FDA, highlighting its potential importance in treating a disease with no approved therapies. Following these results, Lipella plans to engage the FDA for regulatory approval pathways.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced the formation of a five-member Scientific Advisory Board focused on advancing LP-310, a liposomal tacrolimus oral rinse for treating symptomatic oral lichen planus (OLP). The Board will guide the development of a Phase 2a clinical trial for LP-310, seeking IND submission. OLP affects over six million Americans, presenting a significant unmet medical need. Dr. Jonathan Kaufman, CEO of Lipella, expressed confidence in the expertise of the Board members, who bring extensive qualifications in oral medicine. Lipella aims to leverage the 505(b)(2) regulatory pathway for developing LP-310, holding the intellectual property rights for its formulation.

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) announced positive top-line results from its Phase 2a clinical trial of LP-10 for treating Hemorrhagic Cystitis, a rare condition with no current FDA-approved treatments. Conducted on 13 subjects, the trial showed all participants tolerated the drug without serious adverse events. Key findings included decreased hematuria, reduced cystoscopic bleeding, and improved urinary symptoms. The next step involves discussions with the FDA regarding regulatory approval. This marks a significant milestone for Lipella in addressing the unmet needs of cancer survivors suffering from this condition.