Agios: FDA pinalawig ang PYRUKYND thalassemia sNDA PDUFA hanggang Disyembre 7, 2025

Pinalawig ng FDA ang PDUFA goal date para sa PYRUKYND sNDA sa thalassemia ng tatlong buwan hanggang Disyembre 7, 2025 matapos humiling ng REMS dahil sa potensyal na panganib ng hepatocellular injury. Ang pagpapalawig ay hindi dahil sa bagong datos ng efficacy o safety; ang aplikasyon ay nananatili sa aktibong pagsusuri ng FDA habang nagpapatuloy ang mga paghahanda para sa U.S. launch.

Mahahalagang fact

Na-file: Okt 30, 2025, 10:32 AM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Negatibo
Kumpanya: AGIOAgios
Asset: mitapivat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 1, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 agio-103125xfyxex991earnin.htm EX-99.1 Document Exhibit 99.1 Agios Reports Third Quarter 2025 Financial Results and Provides Business Update • $12.9 million in third quarter PYRUKYND® (mitapivat) net revenues • PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025 • CHMP adopted positive opinion for PYRUKYND in thalassemia; EC decision expected by early 2026 • RISE UP Phase 3 trial topline results in sickle cell disease by year-end; potential U.S. commercial launch in 2026 • Phase 2b tebapivat trial in lower-risk MDS fully enrolled; topline results expected in early 2026 • $1.3 billion dollars in cash, cash equivalents and marketable securities as of September 30, 2025 CAMBRIDGE, Mass. , October 30, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO),

SEC 8-K