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CLAIM #48357 · Pfizer Inc (PFE) · 2024Q1 earnings call · May 1, 2024 · due Dec 31, 2024

We expect an FDA decision before year end for marstacimab, which has the potential to become the first once-weekly subcutaneous treatment for the hemophilia B market, and the first treatment delivered as a flat dose for both hemophilia A and hemophilia B.

Albert Bourla · CEO

PENDING
graded after results covering Dec 31, 2024 are reported

In context

recently reported positive results from the Phase III MONeT trial, evaluating ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease. The trial met its primary endpoints, and we intend to submit these data to regulatory agencies. We believe ABRYSVO has the potential to become the first and only RSV vaccine for adults 18 years and older. Hematology is another priority area. With the progress of recent and near-term milestones, we are confident that we could establish a potential multi-billion-dollar product portfolio across hemophilia and sickle cell disease. We recently received the first U.S. FDA gene therapy approval for Pfizer with FDA approval for BEQVEZ, a one-time gene therapy for adults with hemophilia B. This program builds upon our growing presence in hemophilia. We expect an FDA decision before year end for marstacimab, which has the potential to become the first once-weekly subcutaneous treatment for the hemophilia B market, and the first treatment delivered as a flat dose for both hemophilia A and hemophilia B. Moving to sickle cell. We recently started the Phase III study of osivelotor, our potentially best-in-class next-generation hemoglobin S polymerization inhibitor. We are committed to addressing the underserved needs of the sickle cell disease community, and we are leveraging our capabilities for potential breakthroughs for these patients. Now, I'll turn to our strategic priority of maximizing performance of our new products. While it may take a year to realize the full benefit of the changes we put in place, as we speak, to bring a more efficient structure to our commercial operations, we are pleased by the impact we are already seeing from our sharpened focus and Pfizer colleagues embracing our high-performance culture. Earlier, I mentioned the momentum of our Oncology products. Ou

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SEC filings for PFE · Claim quote is verbatim from the 2024Q1 earnings call.