Following the announcement, the stock jumped by more than 15%.
FDA Sets November Decision Date For Agios Sickle Cell Disease Drug
The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1.
The FDA’s Priority Review designation is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions, shortening the target review timeline from the standard 10 months to six months.
RISE UP Data Supports Mitapivat Filing
