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FCR 001

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Drug Profile

FCR 001

Alternative Names: Facilitating Cell Therapy - Novartis/Tourmaline Bio; FCR-001; FCRx - Novartis/Tourmaline Bio; Haematopoietic stem cell therapies - Novartis/Tourmaline Bio

Latest Information Update: 20 Oct 2023

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At a glance

  • Originator Regenerex LLC
  • Developer Tourmaline Bio
  • Class Haematopoietic stem cells therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

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

    Yes - Renal transplant rejection
  • New Molecular Entity No

Highest Development Phases

  • Phase II Diffuse scleroderma
  • Preclinical Blood dyscrasias; Metabolic disorders
  • No development reported Autoimmune disorders
  • Discontinued Renal transplant rejection

Most Recent Events

  • 19 Oct 2023 Talaris Therapeutics has merged with Tourmaline Bio to form Tourmaline Bio
  • 10 Oct 2023 Talaris Therapeutics withdraws a phase I/II FREEDOM-3 trial prior to enrolment in Diffuse scleroderma in USA (IV, Infusion) due to sponsor's decision to terminate all clinical development programs (NCT05098145)
  • 14 Aug 2023 ImmunoFree acquires all rights to FCR 001 from Talaris Therapeutics

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