The world’s only database of publicly announced RMAT designations that is searchable, sortable, and continuously updated.
To date, 83 RMAT designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 238 requests and issued 92.
Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (92 approvals / 238 applications = 38.7%).
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, nine companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Cook MyoSite, Humacyte, Mesoblast, and Orchard Therapeutics) have managed to secure two RMAT designations from the U.S. FDA.
RMAT Designations
RMAT stands for “Regenerative Medicine Advanced Therapy” designation. 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. While cell and gene therapies have been the most common recipients of RMAT awards, tissue engineering and combination products can also received them.
Since the RMAT designation was introduced in 2017, BioInformant’s team of analysts have maintained a searchable, sortable database of every publicly known approval (currently 83 total).
It was originally developed in-house for our own purposes, but we had more and more clients requesting access to it.
The database presents all known RMAT recipients, including:
- Company Name
- Product Name
- Medical Indication
- Date of Approval
- Product Category (Cell Therapy, Gene Therapy, Tissue or Combination Product)
- Company Website
- Link to RMAT Announcement
Because RMAT designations allow for faster, more streamlined approvals of regenerative medicine products within the U.S., this database reveals the identities of the most innovative competitors within the marketplace.
In addition to identifying products under development and the conditions they treat, the database allows you to assess the year-over-year increase in RMAT designations over time.
Because it is an essential resource within our company, we’re confident it will be a valuable resource for you too.
For a brief time, you can claim this comprehensive RMAT Database for only $75 (25% off).