BTIG launched coverage of Intra-Cellular Therapies (NASDAQ:ITCI) with a “buy” rating and $44 price target, saying there is considerable promise for the company’s antipsychotic, ITI-007, in multiple indications. The stock closed at $15.05 on Dec. 21.
“We believe [the company] can successfully develop the unique late-stage antipsychotic, ITI-007, in several large CNS indications, including schizophrenia, agitation with dementias, bipolar depression and others, creating peak revenue potential of several-billion dollars, including line extensions,” writes analyst Robert Hazlett. The company also is developing PDE inhibitors for CNS uses.
He said 60mg ITI-007 demonstrated positive efficacy in schizophrenia in a large Phase 2 trial and in one Phase 3 study, although in a second pivotal study with a slightly different design, it did not.
“Nevertheless, we believe 007’s NDA for schizophrenia can be filed in 2017 and approved in 2018, with peak schizophrenia revenue of $1.5-billion, as 007 appears differentiated, with no difference versus placebo in movement disturbances (akathisia), prolactin, body weight, glucose, insulin, and lipid elevations,” Mr. Hazlett said.
ITI-007 also is in a Phase 3 trial in bipolar depression and in behavioral disturbances in dementia, material indications in their own right. “We estimate its collective potential across these indications exceeds $4-billion at peak,” he added.
