原始出處紀錄
決策級FDA 核准
BioCryst：FDA 核准 ORLADEYO 口服顆粒用於小兒 HAE
FDA 核准 NDA，針對每日一次 ORLADEYO（berotralstat）口服顆粒製劑，用於 2 至未滿 12 歲兒童遺傳性血管性水腫的預防性治療。此舉將核准適應症從成人／青少年擴大至此兒童族群，為首個且唯一的口服預防性選擇。
關鍵事實
- 申報時間
- 2025年12月12日 下午12:51
- 事件
- FDA 核准
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
Form 8-K False 0000882796 0000882796 2025-12-12 2025-12-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 8-K _________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 12, 2025 _______________________________ BioCryst Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) _______________________________ Delaware 000-23186 62-1413174 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 4505 Emperor Blvd., Suite 200 Durham , North Carolina 27703 (Address of Principal Executive Offices) (Zip Code) ( 919 ) 859-1302 (