To date, 66 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 187 requests and issued 70, 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, AlloVir is the only company to receive three RMATs, while six companies (Abeona Therapeutics, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Rocket Pharmaceuticals, and CRISPR Therapeutics) have received two RMAT designations from the U.S. FDA.