Biogen & Eisai Initiate PMDA’s Process for Lecanemab in Japan

Biotech firm Biogen Inc. (NASDAQ: BIIB) and Japan-based global pharmaceutical company Eisai Co., Ltd. have revealed that Eisai is in the process of submitting an application to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for lecanemab (BAN2401). 

Lecanemab, the investigational anti-amyloid beta (Aβ) protofibril antibody, is designed to treat early Alzheimer’s disease (AD). Remarkably, the lecanemab Clarity AD Phase 3 clinical study is ongoing. 

Details of the Development

Known as “prior assessment consultation,” the PMDA process is conducted to smoothen the review process. This occurs prior to the new drug application submission.

Consequently, following discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai has submitted the non-clinical lecanemab data to reduce the review period. Post-submission of the additional data, the primary endpoint data from the Clarity AD study is expected in the fall of 2022. 

Following the declaration of study results, the application for manufacturing and marketing approval is likely to be filed in Japan during Eisai’s Fiscal Year 2022. 

Other Approvals 

In September 2021, A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for lecanemab, with the completion of submission expected at the beginning of Eisai’s Fiscal Year 2022. The trial included participants with early AD and confirmed amyloid Pathology.

Hedge Fund Activity

TipRanks’ Hedge Fund Trading Activity tool shows that confidence in Biogen is currently positive, as the cumulative change in holdings across all 18 hedge funds that were active in the last quarter represented an increase of 330,000 shares.

Wall Street’s Take 

Recently, RBC Capital analyst Brian Abrahams upgraded Biogen to a Buy from Hold rating, and lifted the price target to $248. This new target now indicates a possible 9.25% upside potential from his previous $227.  

Abrahams commented, “Challenges clearly remain but with sentiment at a low, upside/downside now looks more attractive.” 

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 14 Buys and 13 Holds. The average Biogen price target of $259.71 implies 22.81% upside potential, as of intradat trading on Monday, at 12:55pm.

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