Brief: FDA Accepts Agios' Supplemental New Drug Application For Pyrukynd® (Mitapivat)

Agios Pharmaceuticals

08/01/2025 12:04

Jan 8 (Reuters) - Agios Pharmaceuticals Inc  AGIO.O :
    * FDA ACCEPTS AGIOS’ SUPPLEMENTAL NEW DRUG APPLICATION FOR
PYRUKYND® (MITAPIVAT) IN ADULT PATIENTS WITH
NON-TRANSFUSION-DEPENDENT AND TRANSFUSION-DEPENDENT ALPHA- OR
BETA-THALASSEMIA
    * AGIOS PHARMACEUTICALS INC - PDUFA GOAL DATE FOR PYRUKYND
SNDA IS
SEPTEMBER 7, 2025

Source text:  ID:nGNX5SDZYJ 
Further company coverage:  AGIO.O 

 ((Reuters.Brief@thomsonreuters.com))