Biogen Alzheimer’s Drug Faces FDA Panel With Billions at Stake - (Bloomberg via NewsPoints Desk)

  • 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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