Dyne Therapeutics Gets New FDA Orphan Drug Designation
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Dow Jones
By Sabela Ojea
Dyne Therapeutics said the U.S. Food and Drug Administration granted orphan drug designation to its DYNE-101 treatment, which targets the multisystem disorder Myotonic Dystrophy Type 1.
The biotechnology company on Wednesday said that DYNE-101 is being evaluated in the Phase 1/2 global achieve clinical trial with initial data on safety expected for the second half of the year.
The orphan drug designation is granted to drugs or biologics intended for treatment, prevention or diagnosis of a rare disease that affects less than 200,000 people in the U.S.
Write to Sabela Ojea at sabela.ojea@wsj.com
(END) Dow Jones Newswires
September 20, 2023 16:36 ET (20:36 GMT)
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