Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Bio­gen is step­ping out on­to the high wire to­day, re­port­ing that the team work­ing on the con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab has now com­plet­ed their sub­mis­sion to the FDA. And they want the agency to bless it with a pri­or­i­ty re­view that would cut the agency’s de­ci­sion-mak­ing time to a mere 6 months.

The news drove a 10% spike in Bio­gen’s stock $BI­IB ahead of the bell.

Part of that spike can be at­trib­uted to a re­lief ral­ly. Bio­gen ex­ecs rat­tled back­ers and a host of an­a­lysts ear­li­er in the year when they un­ex­pect­ed­ly de­layed their fil­ing to the third quar­ter. That de­lay pro­voked all man­ner of spec­u­la­tion af­ter CEO Michel Vounatsos and R&D chief Al San­drock failed to per­suade in­flu­en­tial ob­servers that the pan­dem­ic and oth­er fac­tors had slowed the time­line for fil­ing. Ac­tu­al­ly mak­ing the pitch at least sat­is­fies skep­tics that the FDA was not like­ly push­ing back as Bio­gen was push­ing in. From the start, Bio­gen ex­ecs claimed that they were do­ing every­thing in co­op­er­a­tion with the FDA, say­ing that reg­u­la­tors had sig­naled their in­ter­est in re­view­ing the sub­mis­sion.

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