ALKS focus is shifting from its marketed to products to its questionable pipeline:
ALKS5461 received refusal to file letter from FDA. PDUFA is 1/31/19. Efficacy is very dubious, but the drug is safe and FDA has a history of being soft on depression medications that don't really work.
ALKS4230 is an IL-2 agonist that was included in a collaboration with NKTR/BMY. Ph1 dose escalation data will be out H2/18. If skepticism about toxicity proves unwarranted, this collaboration has promise.
ALKS3831 will report Ph3 results in a weight gain trial. If approved, this drug will have limited commercial viability
BIIB098 will have an NDA filing Q4/18. There is skepticism surrounding the competitiveness of this drug.