After Agios Pharmaceuticals (AGIO) announced that the FDA has extended the PDUFA goal date for the supplemental New Drug Application for Pyrukynd in adult patients with non-transfusion-dependent and transfusion dependent alpha- or beta-thalassemia by three months to a new action date of December 7, H.C. Wainwright noted that a Risk Evaluation and Mitigation Strategy drug safety program approval is an iterative process and PFUDA delays in such cases are “not uncommon.” The firm, which remains confident in FDA approval by the new PDUFA date, has a Buy rating and $56 price target on Agios shares.
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