Voyager's shares sink after execs say FDA has reversed course on an accelerated filing for its gene therapy
The FDA appears to have lost its appetite for an accelerated marketing application that could pave the way to an early OK for Voyager’s lead gene therapy. The company announced after the market closed Wednesday that the agency’s view has shifted dramatically.
After tantalizing investors in July with its claim that FDA officials said in a Type C exchange that they were open to a filing based on the safety and efficacy seen in a Phase II study for VY-AADC in Parkinson’s disease, the new word is that regulators are now viewing the mid-stage study as a necessary preliminary step to a pivotal trial. In an addendum that arrived in late October, the biotech said, the FDA now says that “although the data from the Phase II trial may support the safety and efficacy of VY-AADC and could be considered in the BLA review, the FDA currently considers the Phase II trial as an early phase exploratory study.”
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