Vertex: Itinakda ng FDA ang Nov 30, 2026 PDUFA para sa povetacicept IgAN BLA

Tinanggap ng FDA ang BLA ng Vertex para sa pinabilis na pag-apruba ng povetacicept sa mga nasa hustong gulang na may IgAN at itinalaga ang target na petsa ng aksyon ng PDUFA na Nobyembre 30, 2026. Ang paghain ay sinusuportahan ng pre-specified na interim analysis sa Linggo 36 mula sa patuloy na Phase 3 RAINIER trial. Kung aprubado, ang povetacicept ay magiging unang nai-market na produkto sa nephrology ng Vertex.

Mahahalagang fact

Na-file: Ago 3, 2026, 08:09 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: VRTXVertex Pharmaceuticals
Asset: povetacicept
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 30, 2026

Sipi mula sa source

EX-99.1 2 ex-991_q22026.htm EX-99.1 Document Vertex Reports Second Quarter 2026 Financial Results — Total revenue of $3.33 billion, a 12% increase compared to second quarter 2025 — — Raising full-year revenue guidance to $13.1 billion to $13.2 billion — — Continued progress across research and development pipeline; povetacicept PDUFA date November 30th — — Entered into agreement to acquire Crinetics Pharmaceuticals, with closing anticipated in the third quarter of 2026 — BOSTON -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the second quarter ended June 30, 2026, and updated its full year 2026 revenue guidance. “Vertex delivered excellent second quarter results, expanding our leadership in cystic fibrosis; delivering strong revenue

SEC 8-K