Shares of Regenxbio (RGNX) were surging premarket Monday after the biotechnology company reported new, positive data from the phase I/II portion of a study evaluating RGX-202 gene therapy for Duchenne muscular dystrophy.
The company also said the gene therapy has advanced to a pivotal stage with a first patient dosed. RGX-202 will now be evaluated in the pivotal trial in about 30 patients aged 1 and older, according to Regenxbio.
Regenxbio also said it is "quickly advancing" the gene therapy toward a biologics license application filing in 2026.
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