FDA Delays Decision On Agios Pharmaceuticals' Blood Disorder Drug For Expanded Use

Core Insights - The FDA has extended the PDUFA goal date for Agios Pharmaceuticals' Pyrukynd sNDA by three months to December 7, 2025, due to a proposed REMS submission [1][2] - The REMS submission is a significant amendment but does not involve new efficacy or safety data [2] - Pyrukynd is supported by Phase 3 trial results and has received approval from the Saudi Food and Drug Authority for similar indications [3][4] Company Developments - Agios Pharmaceuticals has entered a distribution agreement with NewBridge Pharmaceuticals to enhance regulatory filings and commercialization of Pyrukynd in the GCC region [4] - Pyrukynd is approved for treating hemolytic anemia in adults with PK deficiency in the U.S. and for PK deficiency in the EU and Great Britain [4] Market Reaction - AGIO stock has decreased by 15.83%, trading at $34.18 [5]