Biogen Soars As FDA Accepts Alzheimer's Drug For Review In 'Next Stage Of Aducanumab Saga'

Biogen Inc's BIIB investigational Alzheimer's drug aducanumab — a drug for which the company halted studies at one point last year — could finally see the light of day.

What Happened: The FDA accepted the aducanumab biologics license application for priority review, Biogen and partner Eisai Co., Ltd ESALY announced Friday. 

The FDA set a PDUFA goal date of March 27, 2021. 

A priority review means completion of the review six months after the filing of the application, as opposed to the normal timeline of 10 months.

The FDA said it plans to act early on the application if possible. 

Biogen completed submission of the regulatory application July 8, and an announcement concerning the filing sent its shares soaring by 4.4%.

The FDA usually responds within 60 days of the filing of a regulatory application, and in Biogen's case the communication of acceptance came in a month.

The agency said it plans to hold an adcom meeting for the application at date to be determined. 

"The FDA's acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer's disease," Biogen CEO Michel Vounatsos said in a statement. 

SVB Leerink analyst Marc Goodman said in a note that the priority review "is very good news in the next stage of the [aducanumab] saga." 

Why It's Important: Aducanumab, previously known as BIIB037, is an investigational human monoclonal antibody being studied for the treatment of Alzheimer's disease. Alzheimer's drug research is tough terrain to tread, given the difficulty in diagnosing the disease early and lack of understanding of its biological pathway.

Biogen said in March 2019 that it was stopping two late-stage studies of aducanumab, citing an independent data monitoring committee's finding that the trials were unlikely to achieve their primary endpoint.

In October, the company resurrected aducanumab quite unexpectedly by deciding to a file a BLA based on a new analysis conducted of a larger dataset from the discontinued Phase 3 studies.

Biogen shares are likely to continue moving higher as the adcom approaches, as investors increasingly believe that the risk-reward is favorable for owning the name into this event, said SVB Leerink's Goodman. 

"Our valuation for Biogen is $260 excluding the pipeline/adu, and we include 50% POS for adu and thus our PT is $350. With approval our PT would add the other 50% ($90) to drive to $440, so we remain positive and Outperform on the stock." 

BIIB Price Action: At last check, Biogen shares were rallying 8.48% to $301.20 and Eisai was gaining 8.17% to $89.78.

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