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Tovorafenib - Day One Biopharmaceuticals

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Drug Profile

Tovorafenib - Day One Biopharmaceuticals

Alternative Names: AMG-2112819; BIIB 024 - Day One Biopharmaceuticals; BIIB-024; BSK 1369; DAY-101; MLN 2480; OJEMDA; Ojemda; TAK 580

Latest Information Update: 20 May 2026

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At a glance

  • Originator Biogen Idec; Sunesis Pharmaceuticals
  • Developer Day One Biopharmaceuticals; Ipsen; National Cancer Institute (USA); Takeda Oncology
  • Class Amides; Antineoplastics; Pyridines; Pyrimidines; Small molecules; Thiazoles
  • Mechanism of Action Raf kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glioma; Malignant melanoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Glioma
  • Phase II Craniopharyngioma; Langerhans cell histiocytosis; Solid tumours
  • Discontinued Malignant melanoma

Most Recent Events

  • 08 May 2026 Day One Biopharmaceutical completes enrolment in the FIREFLY-2 phase III trial for Glioma (In neonates, In infants, In children, In adolescents, First-line therapy, In adults) in the US, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Jordan, Netherlands, New Zealand, Norway, Qatar, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan and the United Kingdom (NCT05566795)
  • 23 Apr 2026 Day One Biopharmaceuticals has been acquired by Servier
  • 22 Apr 2026 Registered for Glioma (In children, In infants, In adolescents, In adults, Second-line therapy or greater) in European Union, Norway, Iceland, Liechtenstein (PO)

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