FDA Grants Orphan Designation For Lipella's LP-310 Drug Candidate For Oral Graft-Versus-Host Disease
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Lipella Pharmaceuticals Inc. (NASDAQ:LIPO) has been granted 'Orphan Drug Designation' by the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, designed for the treatment of oral Graft-versus-Host Disease (GvHD). LP-310 is Lipella's clinical stage pipeline asset intended for inflammatory diseases of the oral cavity. The FDA's 'Orphan Drug Designation' program provides orphan status to drugs and biologics for the treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S.
November 10, 2023 | 1:03 pm
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Lipella Pharmaceuticals has been granted 'Orphan Drug Designation' for its drug candidate LP-310. This could lead to incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity after approval.
The 'Orphan Drug Designation' granted by the FDA is a significant milestone for Lipella Pharmaceuticals. This designation not only validates the potential of LP-310 but also provides the company with several incentives that could accelerate the drug's development and commercialization. This could potentially lead to an increase in the company's stock price in the short term.
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