other material
confidence high
sentiment positive
materiality 0.75
FibroGen announces positive Phase 3 results for roxadustat in chemotherapy-induced anemia in China
KYNTRA BIO, INC.
- Met primary endpoint: noninferiority to erythropoietin alfa in hemoglobin change from baseline to average weeks 9-13.
- Plan to file supplemental New Drug Application in China with AstraZeneca collaboration.
- 159 non-myeloid malignancy patients enrolled; roxadustat dosed three times weekly for 12 weeks.
- Adverse event profile consistent with prior studies, supporting positive benefit-risk.
- Detailed results to be presented at an upcoming medical conference.