Arcturus Therapeutics Gets FDA Orphan Designation for ARCT-032 in Cystic Fibrosis
28 November 2023 - 1:13AM
Dow Jones News
By Colin Kellaher
Arcturus Therapeutics Holdings has won U.S. Food and Drug
Administration orphan-drug designation for its ARCT-032 product
candidate to treat the life-shortening genetic disease cystic
fibrosis.
The San Diego late-stage clinical messenger RNA medicine company
on Monday said the first patient in its Phase 1b study has
successfully completed two administrations of ARCT-032, adding that
it is on track to share interim data from the study in the first
half of 2024.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended marketing
exclusivity period against competition.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 27, 2023 08:58 ET (13:58 GMT)
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