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]

Core Viewpoint - Pfizer Inc. has received Priority Review from the U.S. FDA for its supplemental Biologics License Application for HYMPAVZI® (marstacimab), aiming to expand its indication for treating hemophilia A or B patients aged 6 years and older with inhibitors, as well as pediatric patients aged 6 to 11 with hemophilia A or B without inhibitors [1] Group 1 - The FDA has accepted Pfizer's supplemental Biologics License Application for HYMPAVZI® [1] - The application seeks to expand the treatment indication to include hemophilia A or B patients aged 6 years and older with inhibitors [1] - The application also targets pediatric patients aged 6 to 11 with hemophilia A or B without inhibitors [1]

Core Insights - Pfizer Inc. presented results from the Phase 3 BASIS study evaluating HYMPAVZI® (marstacimab) for adults and adolescents with hemophilia A or B with inhibitors, showing its superiority in improving key bleeding outcomes compared to on-demand treatment with bypassing agents [1] Group 1: Study Results - The Phase 3 BASIS study demonstrated that HYMPAVZI significantly improved bleeding outcomes [1] - HYMPAVZI is administered via a straightforward, once-weekly subcutaneous injection, requiring minimal preparation [1]