Renaissance Pharma secures FDA fast track designation for daretabart (hu1418K322A) in high risk neuroblastoma

Renaissance Pharma

14 April 2026 - Renaissance Pharma Limited, an Essential Pharma company, today announces that the US FDA has granted fast track designation for daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the treatment of high risk neuroblastoma, a rare paediatric cancer.

Daretabart (hu1418K322A) is being developed by Renaissance Pharma under an exclusive license agreement with St. Jude Children's Research Hospital, a global leader in paediatric cancer research and treatment.

Read Renaissance Pharma press release

Michael Wonder

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Michael Wonder

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Cancer , US , Fast track