Plano ng Agios na magsumite ng sNDA para sa mitapivat sa sickle cell disease sa Q2 2026

Kinumpirma ng Agios na magsusumite ito ng sNDA para sa mitapivat sa sickle cell disease sa ilalim ng FDA accelerated approval pathway sa ikalawang quarter ng 2026 matapos makumpleto ang pre-sNDA meeting nito sa FDA. Ang paghahain ay sumusunod sa mga naunang pag-apruba ng kumpanya sa thalassemia at itinuturing bilang susunod na hakbang sa regulasyon para sa asset.

Mahahalagang fact

Na-file: Abr 29, 2026, 10:32 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: AGIOAgios
Asset: mitapivat
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 agio-42926xfyxex991earning.htm EX-99.1 Document Agios Reports First Quarter 2026 Financial Results and Provides Business Update • Mitapivat (PYRUKYND® and AQVESME™) generated worldwide net revenues of $20.7 million in the first quarter of 2026, compared to $8.7 million in the first quarter of 2025 • Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026 • Company plans to submit mitapivat sNDA for sickle cell disease in the second quarter of 2026 • Pipeline advancing to multiple value-driving inflection points in 2026, including two Phase 2 readouts for next-generation PK activator tebapivat • $1.0 billion in cash, cash equivalents, and marketable securities as of March 31, 2026 CAMBRIDGE, Mass. , Apr. 29, 2026

SEC 8-K