FDA Orphan Drug Designation for Biliary Tract Cancer Treatment Tovecimig (ABL001)
CEO Sang-Hoon Lee of ABL Bio stated, “Compass Therapeutics previously received Fast Track Designation from the FDA for tovecimig in April 2024 and has been leveraging its benefits in clinical development. Based on the COMPANION-002 clinical data, Compass Therapeutics plans to engage with the FDA following the OS and PFS readout on next steps. We hope that this Orphan Drug Designation, following Fast Track Designation, will positively impact the approval process of tovecimig.”
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