Agios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia
(NASDAQ:AGIO) Agios announced that the U.S. FDA has extended the PDUFA goal date for the sNDA of PYRUKYND for adults with thalassemia by three months to December 7, 2025
Related Questions
How will the three‑month PDUFA extension affect AGIO's revenue forecasts and runway for PYRUKYND?
What are the implications of the delay for AGIO's competitive positioning versus other thalassemia therapies in development?
Will the extended timeline impact the company's cash burn rate and potential need for additional financing?