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Biogen Delays Regulatory Filing For Approval Of Alzheimer's Drug, Shares Slump

Biogen Delays Regulatory Filing For Approval Of Alzheimer's Drug, Shares Slump

Biogen Inc (NASDAQ: BIIB) shares were under pressure Wednesday following the release of the biotech's first-quarter report, including the statement that Biogen's BLA filing for its Alzheimer's drug will be delayed.

Issuing an update on the regulatory filing for the Alzheimer's investigational drug it is co-developing with Eisai Co., Ltd (OTC: ESALY), Biogen said it has started submitting modules of the filing.

The company said it has had formal interactions with the FDA using mechanisms such as Type C meetings.

Offering a timeline, the Cambridge, Massachusetts-based company said it is preparing for a pre-BLA meeting with the FDA that's scheduled for the summer.

Biogen said it hopes to complete the BLA filing with the FDA in the third quarter of 2020 as opposed to the initially planned timeline of early 2020.

The company resurrected its almost-dead Alzheimer's investigational drug aducanumab by announcing in October 2019 it is planning to file a BLA following a new analysis.

The sell-side has been divided over the likelihood of the drug receiving FDA approval. 

Biogen reported Wednesday with first-quarter revenue of $3.534 billion, up 1% year-over-year, as revenue from its multiple sclerosis franchise climbed 8% and biosimilar revenues climbed 25%. Non-GAAP EPS rose from $6.98 in 2019 to $9.14 in 2020.

The results exceeded the consensus estimates that called for EPS of $7.73 on revenue of $3.41 billion.

Biogen shares were down 11.68% at $290.59 at the time of publication Wednesday.

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