Biogen Inventory Falls After Analyst Throws Chilly Water on Its Alzheimer’s Drug Wager

Biogen Stock Falls After Analyst Throws Cold Water on Its Alzheimer’s Drug Bet

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Comfortable Monday, readers. I hope you had an exquisite Thanksgiving weekend.

Biogen inventory fell almost 2.5% in Monday buying and selling, shedding almost $2 billion off the biotech large’s market worth. The obvious offender? A scathing investor notice from Baird analyst Brian Skorney that poured chilly water on the prospect of aducanumab, the experimental Alzheimer’s drug that Biogen unexpectedly introduced again from the grave, profitable Meals and Drug Administration (FDA) approval.

For some background: Biogen surprised the biotech neighborhood in late October when it introduced it will be reviving aducanumab and submit it to the FDA for regulatory inexperienced gentle. This extremely uncommon (and doubtlessly unprecedented) transfer got here some seven months after the corporate had deserted late-stage trials of the drug following a “futility evaluation.”

Biogen justified the turnaround by saying {that a} new, extra nuanced evaluation of the dataset confirmed it may, in reality, gradual the speed of cognitive decline in sure Alzheimer’s sufferers. After I spoke with Biogen CEO Michel Vounatsos instantly following the reversal, he struck a assured notice. “The choice was a part of a brand new evaluation of the dataset. The ‘T’s had been crossed and the ‘I’s had been dotted,” he informed me.

Skorney very a lot begs to vary.

“The actual fact is, the prospectively outlined pivotal program failed, making any additional analyses exploratory in nature and any p values reported nominal. To make claims in any other case is statistical malpractice,” he wrote. (P-values are a statistical metric used to evaluate the chance of success that an noticed declare is legitimate.) “The underside line is, the FDA normal of approval is substantial proof of efficacy and the cumulative information for aducanumab falls actually far in need of this normal.”

That bear thesis seems to have no less than some traders shook. Nonetheless, given the shortage of remedy choices within the area, it’s not not possible to think about the FDA may defy the critics and get aducanumab to market.

Biogen declined to touch upon Skorney’s criticism in an emailed assertion.

Learn on for the day’s information.

Sy Mukherjee

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David Noman

David Noman

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