Biogen stock slides 2% after it withdraws authorization application with EU regulator

Biogen Inc. shares fell 2% Friday, after the company said it has withdrawn the marketing authorization application for its controversial Alzheimer’s treatment aducanumab with the European regulator because early communications suggest the data is not sufficient to gain a positive opinion. “We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,” Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen said in a statement. The drug is marketed as aduhelm in the U.S. where it has gained Food and Drug Administration approval, a decision that was widely criticized for being based on questionable data. Biogen has also been slammed for the high cost of the treatment of $56,000 a year. Two lawmakers have called for an investigation into both issues. Biogen shares are down 11% in the year to date, while the SPDR S&P Biotech ETF has fallen 28% and the S&P 500 has fallen 9%.

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