BioCryst Announces FDA Acceptance Of Orladeyo's NDA For Hereditary Angioedema Treatment

(RTTNews) - BioCryst Pharmaceuticals, Inc. (BCRX), Wednesday announced that the U.S. Food and Drug Administration has accepted its New Drug Application for the use of oral, once-daily orladeyo in pediatric patients with hereditary angioedema aged 2 to 11 years.

The acceptance is based on the interim findings of the APeX-P clinical trial, which showed that orladeyo was well tolerated, safe, and reduced monthly attack rates in the participants.

Additionally, the agency has granted Priority Review of the application, with a Prescription Drug User Fee Act target action date of September 12, 2025.

Moreover, the company has also filed its line extension application with the European Medicines Agency for the use of orladeyo oral granules, with expected additional regulatory filings in other countries, such as Japan and Canada.

Tuesday, BioCryst's stock closed at $10.06, down 2.71 percent on the Nasdaq.