Leerink Partners initiated coverage of Intra-Cellular Therapies (NASDAQ:ITCI) with an “outperform” rating and $27 price target. The stock closed at $15.86 on Nov. 14.
Intra-Cellular is focused on development of medicines for neuropsychiatric and neurological disorders, with a fourfold investment thesis, writes analyst Marc Goodman.
He said that the company’s lumateperone drug candidate should get approved for the treatment of schizophrenia based on its strong safety profile relative to other anti-psychotics.
“We think lumateperone has a good chance of working in additional mood disorders (bipolar depression, dementia agitation) based on its distinct pharmacological profile and preliminary clinical evidence … if all are successful,” he added.
Mr. Goodman said the company also has two additional early-stage products: ITI-214 (PDE1 inhibitor) being developed for both Parkinson’s disease and heart failure, and ITI-333 for substance abuse/pain/mood disorders that get “minimal attention and could be sources of upside.”
In addition, he said management has the neurological expertise to deliver more drug candidates through internal discovery and deepen the pipeline.
Mr. Goodman said important catalysts to watch for include:
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An FDA decision on an NDA filing for lumateperone in schizophrenia this month;
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Interim data for lumateperone from a Phase 3 study in agitation associated with dementia in the fourth quarter of 2018;
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Data from the second part of lumateperone’s open label-switching study in schizophrenia, also in the current quarter of 2018; and
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Data from two Phase 3 studies for lumateperone in bipolar depression in the second quarter of 2019.
