RESEARCH TRIANGLE PARK, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12...
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RESEARCH TRIANGLE PARK, N.C.— BioCryst Pharmaceuticals, Inc. today announced that data from the open-label extension (OLE) of the APeX-2 trial of oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older have been published online by the Journal of Allergy and Clinical...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company has appointed regulatory expert and former deputy center director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), Amy McKee, M.D., to its board of directors. Dr. McKee currently serves as vice president of...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company has appointed Helen Thackray, M.D., FAAP, to the newly created position of chief research and development officer. In this role, Dr. Thackray will be responsible for continuing to build the company’s portfolio of rare disease medicines by...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in the REDEEM-1 pivotal trial with its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active comparator-controlled comparison of the efficacy and safety of...
RESEARCH TRIANGLE PARK, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Spanish Ministry for Health (Ministerio de Sanidad) has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “We have an...
RESEARCH TRIANGLE PARK, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients...
RESEARCH TRIANGLE PARK, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new real-world evidence on the use of oral, once-daily ORLADEYO® (berotralstat) demonstrating that patients with hereditary angioedema (HAE) in the United States experience significant reductions in healthcare resource utilization (HRU), including significant reductions in hospitalizations, emergency room visits...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the European Commission (EC) has approved oral, once-daily ORLADEYO™ (berotralstat) for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “As the first targeted oral prophylactic therapy approved in Europe, ORLADEYO represents a major...
RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for oral, once-daily ORLADEYO™ (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “HAE UK welcomes...