(Reuters) – Biogen Inc on Wednesday announced the widely awaited submission of a U.S. marketing application for its experimental Alzheimer’s therapy, aducanumab, sending its shares up more than 8% before the bell.
If approved, aducanumab could become the first treatment to hit the U.S. market to reverse the mental decline caused by the memory-robbing disease, which affects nearly 5.8 million Americans aged 65 and older.
Wall Street analysts have been betting on aducanumab’s success to rewrite Biogen’s growth prospects as it faces concerns over patents of its top-selling drug Tecfidera and competition for Spinraza.
The U.S. Food and Drug Administration now has 60 days to decide whether to accept the application for review, Biogen and partner Eisai Co Ltd said in a joint statement.
Submitting an application is obviously just step 1, and for the stock, the next event that will be telling will be FDA’s acceptance, Stifel analysts wrote in a note.