Shares of Biogen (NASDAQ:BIIB) stock took off on Monday morning, posting gains of more than 50%. The news that has BIIB stock on Wall Street’s watch list today is a major move in the fight against Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) on Monday approved the use of the Biogen’s experimental drug Aduhelm (aducanumab) for early phases of the deadly disease. This comes after an FDA advisory committee said last year that there is not enough evidence of the treatment’s effectiveness.
This is very significant, as Aduhelm is the “first novel therapy approved for Alzheimer’s disease since 2003.” That said, the drug was developed to slow down the development of the disease and not just fight symptoms. Moreover, according to the release, “Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.”
Overall, the FDA approved the drug through its “Accelerated Approval” program, which aims to get treatments approved earlier for serious conditions. Thus, the drug can get into circulation quicker.
What to Know as BIIB Stock Soars Today
Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said this in the agency’s announcement.
“There has been considerable public debate on whether Aduhelm should be approved. … At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. … In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”
BIIB stock was up 50% as of Monday morning.
On the date of publication, Nick Clarkson did not have (either directly or indirectly) any positions in the securities mentioned in this article.
Nick Clarkson is a web editor at InvestorPlace.