Shares of Biogen jumped more than 11% in premarket trading after the company announced the U.S. Food and Drug Administration accepted its Biologics License Application for aducanumab, an investigational treatment for Alzheimer’s disease.
Not only did the regulatory agency accept the BLA, which was submitted last month, it granted Priority Review status, which accelerates the timeline for potential approval. The FDA set a PDUFA target date of March 7, 2021 for aducanumab, Biogen said. But, the FDA could act earlier. Biogen, and its developmental partner Eisai of Japan, noted in its announcement that the FDA stated that, if possible, it plans to act early on this application under an expedited review.