Pfizer trial updates and FDA reviews add pipeline milestones
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
Pfizer reported positive topline Phase 3 results from its BREAKWATER oncology trial in metastatic colorectal cancer with BRAF V600E mutation, announced Phase 2b data for its once monthly, ultra long acting GLP 1 obesity drug candidate, and received Priority Review for a supplemental Biologics License Application for HYMPAVZI seeking expanded use in hemophilia patients. The updates added new clinical and regulatory milestones across oncology, metabolic disease and rare blood disorders.
The company reported Phase 3 MagnetisMM-5 results showing a statistically significant improvement in progression-free survival for relapsed/refractory multiple myeloma. Pfizer and Astellas also announced the U.S. FDA accepted a supplemental Biologics License Application for PADCEV for priority review, advancing a potential label expansion.
The HYMPAVZI review seeks expanded use in hemophilia patients. The cluster of readouts and filings touched three areas where Pfizer is highly active: oncology, obesity and hemophilia.
Pfizer also reached settlements with multiple generics makers that effectively push off generic entry for its VYNDAMAX tafamidis franchise and extend U.S. protection to 2031. In its latest reported quarter, Pfizer posted revenue of $17.56 billion, compared with a consensus estimate of $16.93 billion, while adjusted earnings were $0.66 per share versus consensus estimates of $0.57 per share.