Record mula sa primary source
MateryalNaisumite ang aplikasyon
Nag-sumite ang BioMarin ng sNDA para sa VOXZOGO sa hypochondroplasia
Nag-sumite ang BioMarin ng supplemental NDA sa FDA para sa VOXZOGO (vosoritide) sa hypochondroplasia, ang unang targeted therapy para sa indikasyong ito. Kung aprubado, ang paglulunsad ay nakatakda para sa 2027. Magbibigay ang kumpanya ng update sa status ng aplikasyon sa Q3 earnings release nito.
Mahahalagang fact
- Na-file
- Ago 6, 2026, 08:06 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
BMRNBioMarin- Asset
- vosoritide
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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