Biogen Shares Explode on FDA Approval of Alzheimer’s Drug

Shares of biotech company Biogen were soaring on Monday after Wall Street learned that the Food & Drug Administration has approved the company’s Alzheimer’s drug.

The drug, called aducanumab, is the first new therapy for Alzheimer’s Disease in nearly two decades and

Aducanumab is the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s. The drug is marketed under the name Aduhelm and is expected to generate billions of dollars in revenue for Biogen.

Shares soared over 60% at one point after being halted for the announcement. The stock closed up around 38% at $395.85.

“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

“We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.”

“With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review,” Cavazzoni also said.

The FDA will continue to monitor the drug as it reaches the U.S. market and granted approval on the condition that Biogen conduct another clinical trial.

Biogen said that aducanumab’s list price is $56,000 per year; $4,312 per infusion.

Biogen CEO Michel Vounatsos told CNBC’s “Power Lunch” on Monday that he thought the drug’s price was “fair” and that they would not hike its price for four years.

“It is a new day,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement.

“This approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease.
It is about hope.”

Previously no drugs had been cleared by the FDA that can slow the mental decline from Alzheimer’s.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.