Vertex nasa tamang landas para sa H1 2026 BLA filing ng povetacicept sa IgAN

Ang 8-K ay nagsasaad na nasa tamang landas ang Vertex upang makumpleto ang BLA filing para sa U.S. accelerated approval ng povetacicept sa IgAN sa unang kalahati ng 2026. Ito ay nagtatakda ng isang konkretong regulatory-submission milestone para sa asset. Walang ibang regulatory outcomes o petsa ang ibinigay sa dokumento.

Mahahalagang fact

Na-file: Peb 12, 2026, 09:04 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: VRTXVertex Pharmaceuticals
Asset: povetacicept
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 ex-991_q42025.htm EX-99.1 Document Vertex Reports Fourth Quarter and Full Year 2025 Financial Results — Full year total revenue of $12.0 billion, a 9% increase compared to full year 2024; fourth quarter total revenue of $3.19 billion, a 10% increase compared to fourth quarter 2024 — — Company provides full year 2026 total revenue guidance of $12.95 billion to $13.1 billion, with non-CF products expected to contribu te $500 million or more in reve nue — — Broad mid- and late-stage clinical pipeline accelerates with multiple proof-of-concept and pivotal programs advancing; on track to complete BLA filing for U.S. accelerated approval of povetacicept in IgAN in the first half of 2026 — BOSTON -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financ

SEC 8-K