Arcturus Therapeutics Receives Orphan Drug Designation From The U.S. FDA For ARCT-032, For The Treatment Of Cystic Fibrosis
Portfolio Pulse from Benzinga Newsdesk
Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) has received Orphan Drug Designation from the U.S. FDA for ARCT-032, a treatment for cystic fibrosis. This designation provides various incentives and is a key regulatory milestone. The first patient in a Phase 1b study has completed two administrations of ARCT-032, with interim data expected in H1 2024.
November 27, 2023 | 1:32 pm
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Arcturus Therapeutics received FDA Orphan Drug Designation for ARCT-032, which could lead to market exclusivity and other benefits upon approval.
The Orphan Drug Designation is a positive regulatory development that typically leads to increased investor confidence in the drug's potential and the company's prospects. This can result in a short-term positive impact on the stock price as the market reacts to the news. The designation also comes with benefits that can improve the drug's profitability and reduce development costs, further enhancing the company's value.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100