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0.0118343195266272 0 0 -0.0414201183431953 -0.0295857988165681 0.041360946745562 -0.0147928994082841 -0.0526627218934912
Stock impact report

Prana Receives First Orphan Drug Designation from the FDA for the Treatment of Multiple System Atrophy

PRANA BIOTECH (PRAN) 
US:NASDAQ Investor Relations: pranabio.com/investors
Company Research Source: Business Wire
MELBOURNE, Australia & SAN FRANCISCO--(BUSINESS WIRE)-- Prana Biotechnology Ltd (ASX: PBT, NASDAQ: PRAN) (“Prana” or “the Company”) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its lead molecule, PBT434, for the treatment of Multiple System Atrophy (MSA). This is the first time the FDA has granted orphan designation to a drug for the treatment of MSA. Orphan Drug designation by the FDA entitles Prana to seven years of market exclusivity for the use of PBT434 in the treatment of MSA and qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing. Prana’s successful application was based on the proposed use of PBT434 as a treatment for MSA, including the medical and scientific rationale. The application articulated how PBT434 prevents a-synuclein accumu Show less Read more
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