Alk­er­mes plots course to the FDA af­ter its de­pres­sion drug scores suc­cess in last-stand PhI­II

Just af­ter the start of this year, Alk­er­mes was blast­ed by the news that the first two of three late-stage stud­ies for its de­pres­sion drug ALKS-5461 had failed. An­a­lysts hit the red-alert but­ton and the biotech’s shares $ALKS skid­ded down 44%, wip­ing out $4 bil­lion of mar­ket cap as ex­ecs im­me­di­ate­ly piv­ot­ed and re­searchers scram­bled to sal­vage the third Phase III by re­vamp­ing the tri­al.

To­day, Alk­er­mes says that third tri­al scored a suc­cess. And even though it doesn’t mea­sure up to stan­dard FDA guide­lines, which look for a pos­i­tive read­out from at least two of the three stud­ies, CEO

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