To date, 55 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 173 requests and issued 64, which means that a handful are not yet public knowledge.
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.
Thus far, only four companies (Abeona Therapeutics, Athersys, Rocket Pharmaceuticals, and CRISPR Therapeutics) have received two RMAT designations from the U.S. FDA.
