Posted by Michael Wonder on 23 Jun 2026
Prime Medicine receives US FDA regenerative medicine advanced therapy designation for PM359 for the treatment of chronic granulomatous disease
22 June 2026 - Prime Medicine today announced that the US FDA has granted regenerative medicine advanced therapy designation to PM359, an investigational autologous Prime Edited hematopoietic stem cell therapy for the treatment of p47phox-deficient chronic granulomatous disease.
Regenerative medicine advanced therapy designation was granted based on Phase 1/2 clinical data, including data previously published in The New England Journal of Medicine, and will provide the benefits of intensive FDA guidance and expedited review through the program’s development.
