The FDA’s call for drugs for Alzheimer’s disease is approaching. These analysts are expecting a green light.
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According to analysts, approval of a drug for Alzheimer’s disease does not guarantee significant sales.
Dream time
It’s only a few days before the US Food and Drug Administration (FDA) announces a decision to approve aducanumab. Biogenof
Analysts put their cards on the table about how to treat the controversial Alzheimer’s disease.
Analysts at BTIG and UBS explain in a recently released memo why the FDA is likely to approve the drug. This decision is one of the most anticipated biopharmacy news events in our memory these days, and it doesn’t just move. Biogen
Investors are divided on where the FDA will go. Biogen’s share price closed at $ 269.35 on Wednesday, rising 10% this year. Stock prices fluctuated this week, rising 0.8% on Wednesday and falling 0.1% on Tuesday. Earlier on Thursday, stock prices fell 0.6%.
UBS analyst Colin Bristow wrote in a memo on Wednesday that a former FDA employee he didn’t identify told him that authorities would approve aducanumab with a 60% chance. ..
“Given that it’s been less than a week [FDA deadline], Our experts now see a 60% chance of approval (30% in April), and the FDA points out that the final decision on label / post-marketing requirements is likely to take some time. “I do,” Bristow wrote.
BTIG analyst Thomas Shrader wrote in another note issued Tuesday that he believes Biogen will have a 70% chance of getting approval.
“I admit that the FDA’s jury has made this approval visually more complicated, but the strange tone of the event makes it easier to vote,” Shraders wrote. The FDA Advisory Board, decided in November, has evidence of Biogen The efficacy of aducanumab has not been established.
Both analysts write that large sales are not guaranteed, even if approved. The Institute for Clinical Economic Review, an influential body in drug pricing issues, supported market analysts’ expected annual price of $ 50,000 in a cost-effectiveness analysis in a draft report in early May. He said he couldn’t. ICER has calculated prices between $ 2,560 and $ 8,290. Years of cost-effective medicine.
“Expectations for the spread of adu for approval have weakened a bit,” Bristow wrote in his memo. His financial model points out that on a risk-adjusted basis, 2022 aducanumab sales will be $ 941 million.
BTIG’s Schroeder said on his side that he modeled on “relatively modest peak sales,” primarily for young and motivated patients. He estimates aducanumab sales in 2022 to be $ 537 million on a risk-adjusted basis.
Investors will not have much time to know what the FDA is trying to do. The agency deadline is June 7th, but news may come before that.
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