Leerink says Agios pressure related to deaths listed in FAERS database

Leerink analyst Andrew Berens notes that Agios Pharmaceuticals (AGIO) shares were under pressure on Friday, which the firm says was apparently related to three deaths in Pyrukynd patients that newly appeared in the FDA’s Adverse Events Reporting System, or FAERS, database in July. Two of the recent deaths were in young patients and added to the database on July 9 and another was added on July 15, according to the analyst, who noted that those brought the total to four cases since the drug has launched. The FAERS database “can be an important tool in the surveillance of drugs’ post-market safety, but it is also often limited by the lack of details and context,” noted the analyst, who finds these FAERS additions “potentially concerning,” but also thinks it is difficult to “put them in context without additional data.” The firm maintains a Market Perform rating on Agios shares, pending clarity.