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

Biogen inventory fell practically 2.5% in Monday buying and selling, shedding practically $2 billion off the biotech big’s market worth. The obvious wrongdoer? A scathing investor observe 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, successful Meals and Drug Administration (FDA) approval.

For some background: Biogen surprised the biotech group in late October when it introduced it might be reviving aducanumab and submit it to the FDA for regulatory inexperienced mild. This extremely uncommon (and probably 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 might, actually, gradual the speed of cognitive decline in sure Alzheimer’s sufferers. Once I spoke with Biogen CEO Michel Vounatsos instantly following the reversal, he struck a assured observe. “The choice was a part of a brand new evaluation of the dataset. The ‘T’s have been crossed and the ‘I’s have been dotted,” he instructed 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 likelihood of success that an noticed declare is legitimate.) “The underside line is, the FDA customary of approval is substantial proof of efficacy and the cumulative information for aducanumab falls actually far in need of this customary.”

That bear thesis seems to have at the least some traders shook. Nonetheless, given the dearth of therapy choices within the area, it’s not inconceivable to think about the FDA might 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