BioCryst Pharmaceuticals, Inc. (BCRX) on Friday said the U.S. Food and Drug Administration has approved an oral pellet formulation of Orladeyo for prophylactic use in pediatric patients aged 2 to under 12 years with hereditary angioedema (HAE).
With the new approval, Orladeyo becomes the first and only targeted oral prophylactic therapy available for HAE patients aged 2 and older. The capsule form of Orladeyo is already approved for patients aged 12 and older and is available in more than 45 countries, including the U.S.
BioCryst shares rose more than 8% in pre-market trading after closing at $7.58 on Thursday, down 1.04%.
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