Prime Medicine, Inc.
PM359
Chronic Granulomatous Disease (CGD)
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on PM359 for Chronic Granulomatous Disease (CGD) is expected Date TBD.
Primary source
· SEC 8-K
verified 13h ago
“This begins with PM359, our ex vivo Prime Edited autologous HSC product for CGD, for which we announced breakthrough data in 2025, which we believe supports an accelerated approval in the United States.”