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Biogen (BIIB) Stock Crashes 30% As FDA Tears Down Alzheimer's Treatment, Prompting Multiple Downgrades

November 9, 2020 8:53 AM

Shares of Biogen (NASDAQ: BIIB) are down 30.4% in pre-open trading Monday after a Food and Drug Administration (FDA) advisory panel nearly unanimously voted against the company’s experimental Alzheimer’s disease therapy.

Biogen’s product received no votes in favor while 10 voted “no” and 1 was uncertain on the risk/benefit of the study.

“Biogen thanks the many patients and advocates who shared their personal thoughts and experience at today’s Advisory Committee meeting, reflecting the significant unmet need for a treatment for Alzheimer’s,” said Michel Vounatsos, Chief Executive Officer at Biogen.

“We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”

Following the vote and opinion from the advisory committee, analysts believe that is now “virtually impossible” to get an approval for the treatment.

BofA Securities Geoff Meacham downgraded BIIB to “Underperform” and slashed the price target to $240.00 per share from $360.00.

“We upgraded on Weds (from U/P to N) given the unqualified support of the agency, but now we now struggle how to envision a way the agency can salvage anything positive based on unequivocally negative AdComm,” Meacham said in today’s note.

“We recognize instances where regulators have approved agents in direct contradiction to a negative panel (e.g., eteplirsen), but we think the political fallout here would be significant—and engender major payer pushback and physician uncertainty. Ultimately, we think Biogen is likely to perform another clinical study; we recognize the desire to maintain a confident stance, but the refusal to restart confirmatory studies seems ill conceived considering all the data issues.”

Similarly, Cowen analyst Phil Nadeau downgraded to “Market Perform” from “Outperform” and cut the price objective from $275.00 to $215.00.

“The discussion and subsequent votes were a resounding and near unanimous rebuke of aducanumab, BIIB and the FDA's clinical reviewers. FDA approval of aducanumab would now appear quite unlikely. Admittedly it is not impossible as the FDA clinical team clearly wanted aducanumab to be on the market and as the FDA is not bound to follow the Ad. Com.'s recommendation. Nonetheless, we think the FDA will probably not go against such a public and resounding rebuke, particularly given the internal disagreement,” Nadeau wrote in a note sent on Monday.

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