ESALF - Biogen rises 10% after FDA extends review period for aducanumab application

The FDA has extended the review period by three months for Biogen (BIIB) and Eisai's (ESALF) Biologics License Application ((BLA)) for aducanumab, an investigational treatment for Alzheimer’s disease.The updated PDUFA action date is June 7, 2021. Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which was considered as a major amendment that will require additional time for review. Biogen licensed aducanumab from Neurimmune and since October 2017, Biogen and Eisai have collaborated on the development of aducanumab globally.BIIB shares up 10% premarket.

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Biogen rises 10% after FDA extends review period for aducanumab application