Biogen CEO Michel Vounatsos told CNBC he remains "confident" the company's Alzheimer's drug will receive FDA approval.
The Cambridge, Mass.-based drugmaker halted two late-stage trials for the drug, called aducanumab, last March after an analysis showed the drug was unlikely to work.
After the setback, Biogen lost billions of dollars in market value.
On Oct. 22, Biogen said it was seeking regulatory approval for the drug. Shortly after the announcement, the company's shares spiked by more than 26 percent.
The drugmaker said its decision to seek approval came after a new analysis of a larger dataset showed the drug reduced clinical decline in patients with early Alzheimer's and that patients who received the drug "experienced significant benefits on measures of cognition and function such as memory, orientation, and language."
Although some drugs are approved to help reduce the symptoms of Alzheimer's, there are no drugs approved to reverse the mental decline from the disease.