Biogen’s remaining options to bolster aducanumab’s case as PDUFA is extended

It’s unclear whether FDA is calling for more data from Biogen because it is looking for a rationale to approve aducanumab against the recommendation of its advisers, or whether it’s primarily stalling for time, avoiding the controversy until a new FDA commissioner is chosen.

Investors viewed Friday’s news that the agency had pushed back the amyloid mAb’s PDUFA date from March 7 to June 7 as a positive sign, sending shares of Biogen Inc. (NASDAQ:BIIB) up $14.74 to $282.61 and adding $2.3 billion to its market cap. The biotech was up twice as much earlier in the day but gave back some gains...