A scientist works in a lab at Biogen in Cambridge, MA on Nov. 5, 2016.Suzanne Kreiter | Boston Globe | Getty PhotosBiogen happy shareholders this w
A scientist works in a lab at Biogen in Cambridge, MA on Nov. 5, 2016.
Suzanne Kreiter | Boston Globe | Getty Photos
Biogen happy shareholders this week after it introduced extra information on its late-stage Alzheimer’s drug, aducanumab.
Shares of the biotech agency closed up 3.41% on Thursday as analysts pointed to a scarcity of any new negatives in contrast with the aducanumab outcomes launched in October, which can improve the drug’s odds of approval with the Food and Drug Administration.
The Cambridge, Massachusetts-based firm nonetheless faces an uphill battle with the federal regulator, nevertheless.
The information, introduced on the Medical Trials on Alzheimer’s Illness convention in San Diego, have been considerably combined, analysts famous. One among two late-stage trials from Biogen confirmed that aducanumab appeared to fulfill its purpose of lowering decline in sufferers, whereas the opposite trial didn’t. To alleviate any considerations that the outcomes have been a fluke, the FDA may ask Biogen to do a further trial earlier than contemplating approval as an alternative of postmarket, analysts say.
“It is a full coin flip that may now be within the fingers of the FDA,” mentioned Jared Holz, a health-care strategist at Jefferies, who put the probabilities of regulatory approval at 60%.
Public stress on regulators
The FDA can be below immense stress from advocacy teams, sufferers and households residing with the illness to…