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(RTTNews) - REGENXBIO (RGNX) announced that the FDA placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I, also known as Hurler syndrome, following preliminary analysis of a single case of neoplasm in a participant treated in its Phase I/II study. The FDA also placed a clinical hold on RGX-121, for the treatment of MPS II, also known as Hunter Syndrome, citing the similarities in products, and shared risk.
"We are surprised by FDA's decision to place our RGX-121 program on hold while the investigation of this single, inconclusive incident in RGX-111 continues," said Curran Simpson, CEO of REGENXBIO.
In pre-market trading on NasdaqGS, REGENXBIO shares are down 30.3 percent to $9.34.
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