Biogen stock skyrockets on news FDA may back its Alzheimer’s drug

RESEARCH TRIANGLE PARK – Biogen stock soared 36% today on news FDA apparently is set to recommend approval of its treatment for Alzheimer’s.

Results from one of two Phase 3 trials are “highly persuasive,” financial news site SeekingAlpha reported, adding the study is “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness of aducanumab.”

“Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval,” FDA staff explained in a document reviewing the drug, according to CNBC.

Investors acted quickly.

“Based on aspects of the FDA briefing document, investors are clearly expecting a thumbs up from the committee considering the urgent need for a therapy to delay, halt or reverse the processes that lead to the clinical deficits that characterize AD,” SeekingAlpha reported.

A meeting is set for Friday to discuss the drug.

At one point Biogen and partner Eisai had pulled the drug after earlier trial results were not promising.

“Subsequent analyses and collaborative meetings with the FDA review team turned the tide however,” SeekingAlpha added.

Biogen (Nasdaq: BIIB) has a significant presence in RTP.