FCR-001 is a Cell Therapy owned by Talaris Therapeutics, and is involved in 6 clinical trials, of which 1 was completed, 4 are ongoing, and 1 is planned.

FCR-001 (FCRx) is a bioengineered bone marrow product that includes hematopoietic stem cells (HSC) and FC establishes mixed chimerism to induce immune tolerance for organ transplantation. Chimerism eventually render the recipient tolerant to cell, tissue or organ transplants from the same donor, thereby enabling transplant patients to build stable immunological tolerance. It exhibits its therapeutic intervention to GVHD by suppressing the immune responses in transplanted patients.

The revenue for FCR-001 is expected to reach a total of $4.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the FCR-001 NPV Report.

FCR-001 was originated by University of Louisville and is currently owned by Talaris Therapeutics.

FCR-001 Overview

FCR-001 (FCRx) is under development for the treatment kidney transplantation, rapidly progressive diffuse scleroderma, auto immune or immune mediated disorder and non-malignant blood, immune, metabolic disorders . It is administered as intravenous infusion. This therapeutic candidate consists of allogeneic hematopoietic stem cells (HSC) that contains CD8+/TCR- facilitating cells (Fc) derived from a donor, enhances engraftment of stem cells in mismatched recipients without causing GVHD. This stem cell therapy is based on Facilitating Cell Therapy (FCRx) platform.

Talaris Therapeutics Overview

Talaris Therapeutics, formerly Regenerex, is a biotechnology company that discovers and develops cell therapies. It is investigating its lead product candidate FCR001 for living and deceased donor kidney transplant (LDKT), and LDKT delayed tolerance induction. The company is also evaluating FCR001 against scleroderma, non-malignant blood, immune and metabolic disorders. Talaris Therapeutics approach is based in its proprietary facilitated Allo-HSCT therapy, that induces immune tolerance by creating chimerism, a state in which the donor’s and the recipient’s HSCs (hematopoietic stem cells) co-exist in the recipient’s bone marrow and produces blood and immune cells of donor and recipient origin. It operates a cell processing facility in Kentucky, the US; and carries additional research operations in Texas, the US. Talaris Therapeutics is headquartered in Boston, Massachusetts, the US.

The operating loss of the company was US$47.5 million in FY2021, compared to an operating loss of US$22.7 million in FY2020. The net loss of the company was US$47.8 million in FY2021, compared to a net loss of US$22.7 million in FY2020.

Quick View – FCR-001

Report Segments
  • Innovator
Drug Name
  • FCR-001
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
  • Non Malignant Disorders
Key Companies
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.