Novartis' TGFβ Targeted Antibody Secures FDA Orphan Drug Tag For Pancreatic Cancer

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  • The FDA has granted Orphan Drug Designation to Novartis AG's NVS NIS793 in combination with standard of care chemotherapy to treat pancreatic cancer.
  • NIS793 is a fully human anti-TGF-β IgG2 monoclonal antibody designed to inhibit the TGF-β pathway in tumor cells and modulate the tumor microenvironment.
  • A Phase 2 study is ongoing, and a Phase 3 trial in the first-line metastatic pancreatic ductal carcinoma is planned to start enrolling patients later in 2021.
  • Price Action: NVS shares are up 0.27% at $91.21 during the market session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
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