- The European Medicines Agency (EMA) has validated and accepted Hutchmed (China) Limited's HCM marketing application seeking approval for surufatinib for pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).
- The EMA's validation confirms that the submission is sufficiently complete and ready to commence the formal review process.
- Recently, the FDA accepted the surufatinib application for the above indication.
- Surufatinib selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors and fibroblast growth factor receptor, inhibiting angiogenesis and colony-stimulating factor-1 receptor, which regulates tumor-associated macrophages promoting the body's immune response against tumor cells.
- Price Action: HCM shares are up 5.3% at $40.10 during the premarket session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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