In presentation slides at the JPMorgan Healthcare Conference, Alkermes today said it sees “significant” news flow in 2019. In schizophrenia, the company expects to report topline results from its Phase 3b Aristada-Invega Sustenna study in the first half of the year. It also expects to present Enlighten-2 data at a medical meeting and submit a new drug application around mid-year. In multiple sclerosis, Alkermes sees reporting topline data for diroximel fumarate in a head-to-head study versus Tecfidera around mid-year. For its immuno-oncology candidate ALKS 4230, the company plans to initiate a subcutaneous study in Q1. It also expects to complete a monotherapy dose-escalation stage of a Phase 1 study and to initiate a monotherapy dose-expansion stage of a Phase 1 study. For depression candidate ALKS 5461, Alkermes said it will determine the drug’s next steps with the FDA action date on January 31 of this year. Shares of Alkermes are up 2%, or 69c, to $31.29 in afternoon trading.
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