Voyager's Parkinson's Gene Therapy Poised For Pivotal Trial Exploration
The Cambridge, Mass.-based biotech announced updated data from a Phase Ib trial of a gene therapy for Parkinson's disease, showing improvements in motor function and less time with dyskinesia.
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The gene therapy developer described Sanofi's decision to give up ex-US rights to VY-AADC01 as good news, but its stock price fell anyway. Voyager maintains that it wasn't necessarily counting on its partner to opt in, so it has enough funding without Sanofi to conduct a Phase II/III study.
It isn’t just the cutting-edge science. Novartis’ landmark approval also highlights regulatory and reimbursement innovation and also may set the rules that the next wave of cell and gene therapies have to follow.
Voretigene neparvovec moves closer to being the first to market a gene therapy in the US with FDA advisory committee review on Oct. 12.