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Myriad Stock Rose on FDA Supplementary Premarket Approval

Daniel Collins
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.