Biogen stocks stalled on Friday as an advisory committee met to discuss the future of the company’s controversial Alzheimer’s treatment, Adukanumab.
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This meeting is an important step on the path of potential Food and Drug Administration approval BiogenTreatment of Alzheimer’s (BIIB). Committee members on Friday morning questioned the difference between the two phases of the study – one successful test and one failed.
Salim Syed, an analyst at Mizuho Securities, said in a report to consumers that the three committee members seemed more negative than the others. Biostatist Dr. Scott Emerson expressed concern about the analysis of biogens in two studies. He accused Biogen of shooting first and then drawing Bullsey.
Syed said, “There are many levels in his inquiry.”
Biogen stock stalled
But the FDA itself felt positive about Alzheimer’s treatment during the meeting. Dr. Billy Dunn, Executive Director of Neuroscience’s Dr. Fis, paved the way for testing Biogen Adecunumb and eventually seeking approval despite a Phase 3 failure.
Furthermore, the FDA may lean towards approval with the notification of documents posted on Wednesday. The advisory committee is expected to vote late Friday on whether to recommend approving the drug. But the opinion of the advisory committee is non-binding. The FDA does not always follow the recommendation.
SVB lyrink analyst Mark Goodman said the vote could be split or even negative. He spoke with an Alzheimer’s treatment specialist. The expert noted that the FDA “has an unusually positive opinion about the therapeutic effect of educanumab in the early stages of Alzheimer’s disease,” Goodman said in a report.
“Nevertheless, he predicted a possible split vote (or even a negative vote) at the (Friday’s) advisory committee meeting, as he noted that committee members are generally more cautious by default,” Goodman said.
Discussed the treatment of Alzheimer’s
The vote of the advisory committee meeting will undoubtedly affect the biogen stock. Ahead of the meeting, the FDA posted briefing documents Wednesday regarding Alzheimer’s treatment. Biogen stock soared 44% that day.
The documents suggest that the FDA may ignore the failed 3-phase study and focus on successful late-phase testing as a basis for approval of educanumab.
Nevertheless, the Alzheimer’s expert quoted by Goodman predicts that the FDA will approve Edukunumb even if the advisory committee turns a negative vote.
“Overall, they believe that ginger will eventually be widely used in early patients with Alzheimer’s disease,” said Goodman, a biogen stock analyst at SVB Lirink. “He estimated that about 25% of his practice could immediately qualify for Edukunumb.”
Follow Alison Gatlin on Twitter IBD_AGatlin.
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