US FDA Places Clinical Hold on Regenxbio's Rare Disease Program

US FDA places clinical hold on Regenxbio's rare disease program

Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its experimental gene therapy programs for rare childhood diseases, sending its shares plummeting 30% premarket.

FDA Lifts Clinical Hold on Intellia’s Trial for Gene Editing Therapy Nex-Z in ATTRv-PN, Places Holds on REGENXBIO MPS Trials | NeurologyLive - Clinical Neurology News and Neurology Expert Insights

Intellia’s trial for nex-z in ATTR-CM remains under clinical hold.