LIPO Lipella Pharmaceuticals Inc

PRISM MarketView announces the release of an insightful interview with Lipella Pharmaceuticals’ CEO, Dr. Jonathan Kaufman, discussing the company's recent regulatory accomplishments and how investors stand to benefit.

Lipella Pharmaceuticals was recently granted Orphan Drug Designation by the FDA for LP-410, its drug candidate for oral Graft-versus-Host Disease (GvHD) and previously received Orphan Drug Designation for LP-10 in 2023. With these nods from the FDA, the company is on track to deliver two safe and effective treatments to cancer survivors, with a third therapeutic in its pipeline.

Dr. Kaufman remarked, “Orphan drug development can often be more profitable, entail lower risk and result in faster time to approval than non-orphan therapeutics. Our strategy involves leveraging the 505(b)(2) pathway which we believe will lower cost and allow for a faster approval process by allowing us to bypass Phase 1 trials and immediately initiate Phase 2 clinical trials. It also potentially mitigates risk from a CMC, safety and clinical development standpoint, and offers greater flexibility from the FDA.”

In conversation with PRISM MarketView, Dr. Kaufman discusses the strength of the company’s clinical pipeline, which has expanded significantly over the past 12 months. “We are excited to have been granted Orphan Drug Designation for two candidates targeting serious rare diseases that have a significant impact on patients’ lives and currently have no approved treatment. Our goal is to deliver safe and effective treatments as quickly as possible to the patients who need them most,” said Dr. Kaufman.

The full interview can be found at: https://prismmarketview.com/lipella-pharmaceuticals-expanded-clinical-pipeline-targets-significant-unmet-need/

About Lipella PharmaceuticalsLipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

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PRISM MarketView does not provide investment advice.

Disclaimer

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