Biogen Tumbles After Delay of Alzheimer’s Treatment Submission

Shares of biotech giant Biogen were falling on Wednesday after the company said it would delay the submitting of its Alzheimer’s treatment, aducanumab, for Food and Drug Administration approval.

The company said it expects to finish submission for aducanumab by the end of the third quarter now. This will likely delay and put an FDA decision on the experimental Alzheimer’s drug out to 2021.

This follows earlier guidance for “early 2020” and then “as soon as possible,” Mizuho Securities analyst Salim Syed noted this week.

“Obviously, aducanumab is very unlikely at this point to get an FDA decision in 2020 with a third-quarter 2020 submission planned,” Syed wrote. “It’s even unclear at this point if an advisory committee meeting would occur in 2020. Our guess is this too is now a 2021 event most likely.”

According to RBC Capital Markets analyst Brian, investors will focus on what emerged from those FDA discussions.

“We believe this underscores the complexity of the data and its interpretation, and would likely place completion of regulatory review well beyond the timelines of the general election, reducing any potential motivations for approving the agent despite the mixed data,” he said.

SVB Leerink analyst Marc Goodman stated, “We still expect the turnaround time on approval will be fairly quick.”

“As we have said in the past, the circumstances of this filing are a bit unusual,” Biogen said to Business Daily.

“This timing is not always easy to predict, and Covid-19 increased complexity. We have started to submit modules of the filing, and we continue to have constructive engagement with the FDA.”

The company added, “Overall, we believe we are on track in terms of the potential for approval.”

Disclaimer: We have no position in Biogen Inc. (NASDAQ: BIIB) and have not been compensated for this article.