Agios: FDA nagtakda ng Nov 1, 2026 PDUFA para sa mitapivat sNDA sa sakit na sickle cell

Nagbigay ang FDA ng Priority Review at nagtakda ng PDUFA goal date na November 1, 2026 para sa mitapivat sNDA sa sakit na sickle cell. Ang aplikasyon ay isinumite sa ilalim ng accelerated approval pathway at mangangailangan ng confirmatory Phase 3 trial (REIGNITE) upang mapatunayan ang klinikal na benepisyo. Ito ay nagtatatag ng near-term regulatory decision point para sa potensyal na bagong indikasyon.

Mahahalagang fact

Na-file: Hul 30, 2026, 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-73026xfyxex991earning.htm EX-99.1 Document Agios Reports Second Quarter 2026 Financial Results and Provides Business Update • Mitapivat (PYRUKYND® and AQVESME™) delivered worldwide net revenues of $44.7 million in the second quarter of 2026, compared to $12.5 million in the second quarter of 2025 • Strong U.S. commercial launch of AQVESME in thalassemia, with 442 cumulative prescriptions written as of June 30, 2026 • sNDA for mitapivat granted FDA Priority Review in sickle cell disease with PDUFA goal date of November 1, 2026 • Diversified and expanded late-stage pipeline with licensing of cevidoplenib for immune thrombocytopenia and advancement of AG-236 into Phase 2/3 development for polycythemia vera • $964.8 million in cash, cash equivalents, and marketable securi

SEC 8-K