Record mula sa primary source
Decision-gradePag-apruba ng FDA
BioCryst: Inaprubahan ng FDA ang mga oral pellets ng ORLADEYO para sa pediatric HAE
Inaprubahan ng FDA ang NDA para sa isang oral pellet formulation ng once-daily ORLADEYO (berotralstat) para sa prophylactic treatment ng hereditary angioedema sa mga bata na may edad 2 hanggang <12 taon. Pinalawak nito ang approved indication mula sa mga adult/adolescent patungo sa unang at tanging oral prophylactic option para sa pediatric population na ito.
Mahahalagang fact
- Na-file
- Dis 12, 2025, 12:51 PM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
BCRXBioCryst- Asset
- berotralstat
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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 (