Intra-Cellular Therapies Buy Rating: High Confidence in Caplyta’s Success for MDD Treatment

Needham analyst Ami Fadia reiterated a Buy rating on Intra-Cellular Therapies (ITCI – Research Report) today and set a price target of $82.00.

Ami Fadia has given his Buy rating due to a combination of factors surrounding Intra-Cellular Therapies and their drug Caplyta’s potential in treating Major Depressive Disorder (MDD). Fadia’s confidence is rooted in a 60% probability of success (POS) for upcoming Phase 3 data readouts based on Caplyta’s previous positive results in bipolar depression and its efficacy in patients with mixed features of depression. The trials’ robust design and adequate powering further bolster this optimism. Moreover, the analyst suggests that the safety concerns for Caplyta are largely mitigated given the drug’s performance in prior clinical studies.

Fadia anticipates a significant stock price surge of about 30% if the study 501 yields positive results, due to the aforementioned high POS and the drug’s promising profile. Conversely, he expects a more moderate stock price decline in the event of negative results, reflecting his assessment that such an outcome is less likely, with only a 15% assigned probability. Furthermore, Fadia posits that even if the study narrowly misses its primary endpoints, there is a possibility that subsequent studies could be successful, which may lead to a relatively contained negative impact on the stock price, underlining the rationale behind the Buy rating.

In another report released on April 3, RBC Capital also maintained a Buy rating on the stock with a $86.00 price target.

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Intra-Cellular Therapies (ITCI) Company Description:

Intra-Cellular Therapies, Inc. is a biopharmaceutical company, which focuses on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. Its lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. The company also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer’s disease, and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer’s disease. The company was founded by Paul Greengard and Sharon Mates on August 29, 2013 and is headquartered in New York, NY.