Biogen Inc (NASDAQ: BIIB) is flying in the market this morning, up more than $81, or 36%, per share. There are multiple reasons for the gains. The company not only announced that it plans on submitting an FDA filing, it also announced its financial results for the third quarter of 2019. Here’s what’s going on:
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BIIB Stock Flies After Announcing Planned FDA Submission
The first part of the reason for the gains today has to do with Biogen’s announcement that it plans on filing a Biologics License with the FDA. The news came via press release early this morning.
In the release, BIIB said that it plans on pursuing regulatory approval for aducanumab. The treatment was developed as a potential option for Alzheimer’s disease.
In a Phase 3 study, known as ENGAGE, patients experienced significant benefits in terms of cognition and function. At the moment, there are few options available to AD patients. Should BIIB receive approval, it has a good chance of tackling a large portion of a market that’s expected to grow to be worth more than $10 billion by 2025.
In a statement, Michael Vounatsos, CEO at Biogen, had the following to offer:
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.
Biogen Reports Q3 Financial Results
In a second press release issued early this morning, BIIB reported its financial results for the third quarter of 2019. Here’s what we saw from the report:
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