https://s21.q4cdn.com/317678438/files/doc_financials/2020/q3/Q3-2020-PFE-Earnings-Release.pdfReceived Fast Track designation from the FDA for our Duchenne muscular dystrophy gene therapy program. Plans to begin dosing participants in our Phase 3 clinical study before year’s end.
Along with partner Sangamo, announced that have dosed the first participant in the Phase 3 AFFINE study of SB-525, an investigational gene therapy for hemophilia A patients.
Along with partner OPKO, announced Phase 3 study evaluating somatrogon dosed once weekly in children 3 to less than 18 years of age with growth hormone deficiency met its primary endpoint. Plans to file Biologics License Application with the FDA this quarter.
Have started dosing patients in Phase 1 studies with two of next-generation CDK inhibitor programs in metastatic breast cancer.
BCMA/CD3 bispecific monoclonal antibody generated Phase 1 data supporting a strong clinical signal of efficacy with very high response rates in heavily pretreated multiple myeloma patients. Plans to soon expand the program into a pivotal study and multiple clinical drug combination projects.
New drug application for abrocitinib for the treatment of moderate to severe atopic dermatitis in patients aged 12 and up has been accepted by the FDA and granted Priority Review designation. The European Medicines Agency has also accepted the Marketing Authorization Application for abrocitinib in the same patient population.
Partner, Valneva, announced positive initial results for its second Phase 2 study of its Lyme disease vaccine candidate.
