BioCryst Pharmaceuticals, Inc.（BCRX）資訊與事件BCRXBioCryst Pharmaceuticals, Inc.

BioCryst Receives FDA Approval for Orladeyo Oral Pellet

BioCryst announced the FDA has approved its supplemental new drug application, or sNDA, for use of the oral pellet formulation of once-daily Orladeyo for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg Orladeyo pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered Orladeyo for prophylaxis to prevent attacks of HAE in either capsule or pellet formulation. The Orladeyo pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.

BioCryst Receives Japan Approval for Orladeyo in Pediatric Patients

BioCryst announced that Japan's Ministry of Health, Labor and Welfare has granted marketing approval for once-daily Orladeyo for prophylactic therapy in pediatric patients with hereditary angioedema aged 2 to less than 12 years.

BioCryst Appoints David Jenkins as Chief Scientific Officer

BioCryst (BCRX) announced the appointment of David Jenkins to the newly created position of chief scientific officer, effective immediately, reporting to Sandeep Menon, chief research and development Officer. In this role, Jenkins will build and lead a research team focused on leveraging external innovation, capabilities and partnerships to accelerate the delivery of rare disease therapies to patients. He will be based in the company's Boston office. He most recently served as senior VP, head of research and external innovation at Ipsen (IPSEY).