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Biogen’s headquarters in Cambridge, Massachusetts
Adam Glanzman / Bloomberg
Shares of
Biogen
slipped on Wednesday after an advisory committee of the European Medicines Agency gave a “negative trend vote” to the company’s drug for the treatment of Alzheimer’s aducanumab.
The stock fell 1% to $ 258.93.
The vote in the EU Committee for Medicinal Products for Human Use follows an oral explanation earlier this month.
“Although we are disappointed with the trend, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal,
Biogen
‘s head of global security and regulatory sciences and interim head of research and development, in a statement on Wednesday.
Biogen (ticker: BIIB) will continue to engage with the EU regulator as it considers the next steps towards giving patients access to aducanumab in Europe, said the company. The EU Advisory Committee will meet again in mid-December and is expected to adopt a formal decision on the substance.
Analysts at Jefferies believe a negative recommendation in December is likely at this point.
“Street was at best 50/50 at approval, and investors still did not have high expectations,” the memo from Jefferies said.
The Food and Drug Administration approved the drug in June, although its external panel of experts had advised that the evidence supporting the substance was too weak.
The FDA’s approval of Aduhelm initially sent the Biogen stock up 38.3% in a single day, but criticism of the approval, disappointment at the early rollout and rapid progress with similar drugs from competitors Eli Lilly (LLY) and others have since lowered the stock.
“Even though Adu was approved in the U.S., we think sentiment is unlikely to get much worse on the stock,” said Jefferies analysts, who rate the stock as a $ 400 price target.
The stock has fallen 34% through Tuesday since the drug was approved by the FDA in June.
Write to Karishma Vanjani at karishma.vanjani@dowjones.com
.
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