European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)

Pfizer announces positive topline results from Phase 3 study of Hemophilia B gene therapy candidate

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting

Pfizer presents marstacimab Phase 3 Data at ASH 2023

Demonstrate significant bleed reduction in hemophilia A and B

Thermo Fisher opens biologics site in Lengnau, Switzerland

The state-of-the-art facility provides a pathway from development to large-scale biologics production