REGENXBIO Reports Positive Data From Phase I/II/III CAMPSIITE Trial Of RGX-121

(RTTNews) - REGENXBIO Inc. (RGNX) announced positive data from the Phase I/II/III CAMPSIITE trial of clemidsogene lanparvovec or RGX-121 for the treatment of patients with Mucopolysaccharidosis Type II, also known as Hunter syndrome. Primary endpoint of CSF HS D2S6 reduction at week 16 was met.

The company submitted these longer-term pivotal results to the FDA in response to an information request in the ongoing Biologics License Application review of RGX-121. The FDA is expected to make a decision on the application by February 8, 2026.

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