Biogen's bet that the FDA will approve its experimental Alzheimer's disease drug aducanumab faces a key test on November 6 when an advisory panel reviews results from a pair of studies, reported Bloomberg.
Stifel analyst Paul Matteis called the advisory committee meeting a "major binary event" Biogen, adding that briefing documents, to be made public two days before the meeting, are likely to be a "bigger determinant than usual in dictating how panelists eventually vote."
Cowen analyst Phil Nadeau said Biogen's growth is "heavily dependent" on aducanumab, particularly following the launch of generic versions of its multiple-sclerosis drug, and as its spinal muscular atrophy treatnment Spinraza faces new competition.
Nadeau expects the panel meeting will make shares move 30% in either direction immediately as the drug's approval will dictate Biogen’s revenue path over the coming years.
The FDA is expected to make a decision by March 7, though Biogen has said it could act sooner, and many have argued a decision is likely on the horizon given the advisory committee meeting is coming about four months prior to the target decision date.
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