BIIB's Experimental Alzheimer's Drug Gets FDA Fast Track Tag

Biogen BIIB announced that the FDA has granted fast track designation to its investigational Alzheimer's disease (AD) drug, BIIB080.

How Does the Fast Track Tag Benefit BIIB’s Drug Development?

Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, fill an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earlier.’

A candidate with the fast track designation is also eligible for rolling review. This could allow Biogen to submit completed sections of its regulatory filing for BIIB080 to the FDA as they become available, rather than waiting for the entire application to be complete. This can potentially expedite the review process, as the FDA typically does not begin reviewing a submission until all sections of the application have been filed.

BIIB’s Stock Performance

Shares of Biogen have underperformed the industry year to date, as seen in the chart below.

More on Biogen’s BIIB080

An investigational antisense oligonucleotide (ASO) therapy, BIIB080 is designed to target tau protein for treating AD. An abnormal accumulation of tau in the brain is a hallmark of this disease and is associated with neurodegeneration and cognitive decline.

Biogen is currently evaluating the drug in the phase II CELIA study in individuals with early-stage AD. This study recently completed enrolling patients, and a data readout is expected next year.

The initiation of the CELIA study is supported by data from a phase Ib study on the drug. Data from this early-stage study showed that treatment with BIIB080 led to dose-dependent reductions in tau protein levels in cerebrospinal fluid (CSF) and a decrease in tau buildup in the brain, as seen in PET scans. Additionally, high-dose groups showed positive trends in cognitive and functional measures, suggesting potential clinical benefits.

BIIB080 is being developed by Biogen in partnership with Ionis Pharmaceuticals IONS. The company had in-licensed exclusive global rights to the drug from Ionis in December 2019. Per the agreement terms, Ionis is eligible to receive royalties on potential sales of the drug.

Marketed Drugs in the AD Space

Currently, there are two drugs approved by the FDA in the AD space — Leqembi and Kisunla. Leqembi, which was approved in 2023, is marketed by Japan-based Eisai in partnership with Biogen. Kisunla was developed by Eli Lilly LLY and received the FDA’s approval last year.

Both Biogen/Eisai’s Leqembi and Lilly’s Kisunla are approved to treat early symptomatic AD, which includes mild cognitive impairment or the dementia stage of the disease. The Biogen/Eisai and Lilly drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.

BIIB’s Zacks Rank

Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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