BioCryst Gets FDA Orphan Status for BCX9250 in Fibrodysplasia Ossificans Progressiva
August 31 2022 - 7:43AM
Dow Jones News
By Colin Kellaher
BioCryst Pharmaceuticals Inc. on Wednesday said the U.S. Food
and Drug Administration granted orphan-drug designation to BCX9250
for the treatment of fibrodysplasia ossificans progressiva, an
ultra-rare genetic disorder.
The Durham, N.C., pharmaceutical company said it aims to begin
studies of the ALK-2 inhibitor in patients next year.
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.
Fibrodysplasia ossificans progressiva is a severely disabling
disorder characterized by the irregular formation of bone outside
the normal skeleton.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 31, 2022 07:28 ET (11:28 GMT)
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