Prime Medicine Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)
Prime Medicine announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to PM359 for the treatment of p47(phox)-deficient chronic granulomatous disease (CGD). The designation is based on Phase 1/2 clinical data published in The New England Journal of Medicine, which showed that a single dose drove rapid engraftment and clinically meaningful restoration of immune function in treated patients.
Key figures
- Drug Name
- PM359
- Phase Of Trial
- Phase 1/2
- Treated patients
- 2
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