To date, what number of U.S. FDA approved RMATs have been issued and to whom have they been awarded?
The answer is that 69 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 203 requests and issued 79, which means that a handful are not yet public knowledge.
Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (79 approvals / 203 applications = 38.9%).
Thus far, AlloVir and CRISPR Therapeutics are the only two companies to receive three RMATs, while six companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, and Rocket Pharmaceuticals) have received two RMAT designations from the U.S. FDA.