Intra-Cellular Therapies (ITCI) '007 Seen as Approvable by KOL - Piper Jaffray
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Piper Jaffray analyst Charles Duncan reiterated an Overweight rating and $22 price target on Intra-Cellular Therapies (NASDAQ: ITCI) after the company hosted a call with a psychiatry KOL experienced in schizophrenia treatment and drug development. The doctor sees ‘007 as approvable.
Duncan commented, "While we discussed the potential reasons behind the recent 302 failure, including expectation bias and patient quality, the big take-away is that this doctor sees ‘007 as approvable based on the two existing positive trials (005+301, with supportive observations from 302). This perspective reinforces our out-of-consensus view that the FDA may not require Intra-Cellular to run another trial prior to NDA submission. We believe the FDA may view the existing evidence of anti-psychotic activity and differentiated tolerability from ‘007 as compelling. We also think the common occurrence of failed trials for effective agents in CNS drug development is well-understood by FDA and that 302 will be evaluated in that context. Overall, we see a buying opportunity for patient investors and in advance of regulatory updates and data presentations as soon as YE16, we reiterate OW."
Shares of Intra-Cellular Therapies closed at $15.15 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, FDA
Related EntitiesPiper Jaffray, The Children's Investment Fund (TCI), Charles Duncan
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