BioCryst Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the company's new drug application for ORLADEYO® (berotralstat) oral granules. This extension pertains to the use of the medication in pediatric patients aged 2 to 11 years with hereditary angioedema $(HAE)$. The FDA's decision to extend the deadline by three months, now set for December 12, 2025, follows the submission of additional final reports and formulation data by BioCryst, which were deemed a major amendment to the application. This extension allows the FDA ample time to conduct a thorough review of the new information.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。