Articles tagged with: Regenerative Medicine Advanced Therapy (RMAT) Designation
Press Releases»

Montreal, QC (Press Release) – ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies. The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers.
RMAT designation is granted by the FDA under the 21st …
Press Releases»

San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company focused on leveraging proprietary next-generation, non-viral gene engineering technologies to create life-saving therapeutics, today announced the U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-101, Poseida’s lead CAR-T therapeutic candidate currently in a Phase 1 clinical trial for the treatment of patients with relapsed / refractory multiple myeloma. RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA.
“P-BCMA-101 is the …