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Varegacestat - Immunome

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Drug Profile

Varegacestat - Immunome

Alternative Names: AL-102; BMS 986115; WHG-626

Latest Information Update: 10 Jul 2026

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Ayala Pharmaceuticals; Bristol-Myers Squibb; Novartis
  • Class Amides; Antineoplastics; Benzene derivatives; Benzodiazepines; Fluorinated hydrocarbons; Small molecules
  • Mechanism of Action Amyloid precursor protein secretase inhibitors; Notch signalling pathway inhibitors
  • Orphan Drug Status

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

    Yes - Unspecified; Solid tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Fibroma
  • No development reported Haematological malignancies; Multiple myeloma; Solid tumours

Most Recent Events

  • 08 Jul 2026 US FDA assigns PDUFA action date of 28/04/2027 for Varegacestat for Fibroma (PO, Capsule)
  • 08 Jul 2026 US FDA accepts NDA for Varegacestat for Fibroma (PO, Capsule) for review
  • 02 Jun 2026 Updated efficacy and adverse events data from phase II/III RINGSIDE trial in Fibroma presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)

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