AveXis shares soar after it outlines FDA’s support for a looming pivotal study on SMA
Shares of AveXis $AVXS ripped higher after the market close on Tuesday after the gene therapy biotech outlined the FDA’s acceptance of a small, single arm pivotal study for rare cases of spinal muscular atrophy Type 1 (SMA).
According to the Chicago-based biotech, regulators signed off on a 20-patient study that would use a historical comparison for evaluating efficacy. And that lays a straight path to a pivotal study now slated to begin in the first half of a looming 2017.
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