Pfizer Inc. (PFE) Announces FDA’s Grant of Priority Review for HYMPAVZI® (marstacimab) sBLA

Group 1 - Pfizer Inc. announced that the U.S. FDA accepted and granted Priority Review for its supplemental Biologics License Application for HYMPAVZI, expanding its indication to treat hemophilia A or B patients aged 6 years and older with inhibitors, and pediatric patients with hemophilia A or B without inhibitors [1][2] - The FDA set a Prescription Drug User Fee Act action date for HYMPAVZI in Q2 2026, which, if approved, would offer a once-weekly subcutaneous injection for bleed protection without the need for routine lab monitoring [2] - Pfizer launched the TrumpRx program to make over 30 innovative medicines more accessible and affordable for Americans, providing significant discounts off list prices as part of a broader agreement with the U.S. government [3] Group 2 - Pfizer Inc. is a global biopharmaceutical company focused on the development, manufacturing, and marketing of biopharmaceutical products, aiming to advance wellness and treatment in developing and emerging markets [4]