Myriad Stock Rose on FDA Supplementary Premarket Approval

On June 18, Myriad Genetics (MYGN) announced that the FDA accepted its supplementary premarket approval (or sPMA) application for BRACAnalysis CDx, a companion diagnostic with Pfizer’s (PFE) talazoparib, a PARP (poly ADP ribose polymerase) inhibitor. Pfizer has already filed a new drug application (or NDA) for the approval of talazoparib. The FDA has granted Pfizer’s NDA for talazoparib “priority review” status and provided a Prescription Drug User Fee Act action date of December 2018.