- Intra-Cellular Therapies (ITCI +15.3%) is up on 42% higher volume. The company reported Q4 results yesterday that underwhelmed investors, but buying has picked up today on renewed enthusiasm for its pipeline.
- Cantor's William Tanner, SunTrust's Ed Nash and Cowen's Ritu Baral are all bullish on the company's prospects. Tanner and Baral have $28 (33% upside) price targets on the stock.
- Lead candidate is lumateperone, Fast Track'd in the U.S. for schizophrenia. The company plans to meet with the agency this month ahead of an NDA filing mid-year. The serotonin, dopamine and glutamate modulator is also being developed for bipolar depression (BD), dementia-related behavioral disturbances and neuropsychiatric disorder-associated sleep disturbances.
- Top-line data from a U.S.-based Phase 3 BD study are expected in H2 followed by results from a global BD study in 2019. If all goes well, an NDA will be filed in the U.S. in H2 2019. Preliminary results from a Phase 3 in dementia-associated behavioral disturbances should be available in H2.
- Candidate #2 is PDE inhibitor ITI-214, in Phase 1/2 development for heart failure and Parkinson's disease (PD). Top-line data from the PD study should be released in H2.
- Previously: Intra-Cellular Therapies announces positive topline data from safety switching study with Lumateperone in patients with Schizophrenia; shares ahead 20% premarket (Sept. 7, 2017)
- Now read: Heron Therapeutics: Updates To Thesis And Catalysts Coming Up
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