Catatan sumber primer
MaterialPermohonan diajukan
BioMarin mengajukan sNDA untuk VOXZOGO pada hipokondroplasia
BioMarin mengajukan NDA tambahan ke FDA untuk VOXZOGO (vosoritide) pada hipokondroplasia, terapi bertarget pertama untuk indikasi ini. Jika disetujui, peluncuran ditargetkan pada 2027. Perusahaan akan memberikan pembaruan mengenai status aplikasi dalam rilis laba Q3.
Fakta utama
- Diajukan
- 6 Agu 2026, 20.06
- Peristiwa
- Permohonan diajukan
- Arah
- Positif
- Perusahaan
BMRNBioMarin- Aset
- vosoritide
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 earningsrelease-6aug26ex991.htm EX-99.1 Document Exhibit 99.1 Contact: Investors: Media: Traci McCarty Marni Kottle BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. (415) 455-7558 (650) 374-2803 BioMarin Reports Second Quarter 2026 Financial and Operating Results Second Quarter 2026 Total Revenues Increased 20% Year-over-year to $990 million Stronger Growth Expectations Drive Increased Guidance for Full-year 2026 Total Revenues, VOXZOGO ® , and Non-GAAP Diluted Earnings Per Share (EPS) Addition of GALAFOLD ® and POMBILITI ® + OPFOLDA ® , with Cost Synergies, Expected to Accelerate Revenue Growth, Non-GAAP Diluted EPS Accretion, Non-GAAP Operating Margin Expansion, and Operating Cash Flow through the Mid-2030s Conference Call and Webcast Scheduled Today at 4:30 p.m. ET