New shaking’s from the world of medical research: Biogen (NASDAQ:BIIB) announced Tuesday morning it is planning to file for U.S. regulatory approval for its Alzheimer’s treatment aducanumab after fresh analysis of its clinical trial showed promise. The announcement sent BIIB shares up in early trading.
Biogen and partner Eisai had in March decided to end two late-stage trials of the treatment based on a so-called "futility analysis" of data, which revealed the trials had little hope of succeeding.
Since the Alzheimer drug’s failure, Wall Street has been calling on Biogen to beef up its pipeline through deals, especially at a time when its peers are looking to sign multibillion-dollar acquisitions.
The drugmaker said on Tuesday a new analysis of the discontinued studies, which looked at a larger set of data, showed the drug was "clinically active."
Based on discussions with the Food and Drug Administration, Biogen said it plans to submit a marketing application for aducanumab in early 2020.
According to CEO Michel Vounatsos, "With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients.
"We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta."
Shares opened Tuesday leaped $85.44, or 38.2%, to $308.95
