To date, 47 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 149 requests and issued 55.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
The most recent addition to this list was Orca Bio for its experimental cell therapy, Orca-T. Orca-T is a formulation of hematopoietic stem cells and T cells provided to cancer patients who are eligible for a hematopoietic stem cell transplant (HSCT). Thus far, only two companies (Abeona Therapeutics and Athersys) have received two RMAT designations from the U.S. FDA.