To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 79 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 230 requests and issued 91, 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 (91 approvals / 230 applications = 39.6%).
Thus far, Rocket Pharmaceuticals is the only company to receive four RMATs, while two other companies (AlloVir, CRISPR Therapeutics) have received three RMATs to date.
Additionally, eight companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Humacyte, Mesoblast, and Orchard Therapeutics) have managed to secure two RMAT designations from the U.S. FDA.
