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ITCI

Intra-Cellular

$13.44

0.58 (4.51%)

07:06
07/08/19
07/08
07:06
07/08/19
07:06

Intra-Cellular says Study 401 of lumateperone did not meet primary endpoint

Intra-Cellular Therapiesannounced top-line results from two Phase 3 clinical trials evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. Study 401 was conducted solely in the U.S. A total of 554 patients were randomized 1:1:1 to lumateperone 42 mg, lumateperone 28 mg, or placebo. In this trial, neither dose of lumateperone met the primary endpoint of statistical separation from placebo as measured by change from baseline on the MADRS total score. There was a high placebo response in this trial. Lumateperone 42 mg and 28 mg demonstrated a LS mean reduction from baseline on the MADRS total score of 20.7 points and 18.9 points, respectively, versus 19.7 points on placebo.

  • 31

    Jul

  • 27

    Sep

ITCI Intra-Cellular
$13.44

0.58 (4.51%)

11/13/18
LEER
11/13/18
INITIATION
Target $27
LEER
Outperform
Intra-Cellular initiated with an Outperform at Leerink
Leerink analyst Marc Goodman started Intra-Cellular with an Outperform and $27 price target as he initiates Neuroscience space with a Positive View. The analyst believes the Neuroscience sector is experiencing a "renaissance" as multiple new agents and mechanisms are coming up the pipeline across major therapeutic areas, the number of clinical studies is growing nicely, and the FDA is friendly to innovation in this space, companies are getting smarter about speed-to-market strategies and selecting niche sub-populations to focus on for initial product approvals, payer pushback on usage is much lower than in other categories, and physicians are enthusiastic about new agents. Regarding Intra-Cellular, Goodman believes that lumateperone should get approved for the treatment of schizophrenia and drive about $400M of peak sales for this indication in 2029.
12/12/18
ADAM
12/12/18
NO CHANGE
Target $31
ADAM
Buy
Intra-Cellular's NDA acceptance puts some investors fears to bed, says Canaccord
Canaccord analyst Sumant Kulkarni maintained a Buy rating and $31 price target on Intra-Cellular after the FDA accepted its new drug application for lumateperone for schizophrenia, and granted a PDUFA date of September 27, 2019, which paves the way for the company to potentially have a product on the market next year. In a research note to investors, Kulkarni says the NDA acceptance was expected, but the announcement puts some investor fears to bed. If approved, the analyst believes lumateperone could present a meaningful product for the treatment of schizophrenia given its relatively benign safety/side effect profile vs. the current standard of care.
12/12/18
12/12/18
NO CHANGE
Target $37

Outperform
Intra-Cellular price target raised to $37 from $35 at RBC Capital
As previously reported, RBC Capital analyst Brian Abrahams raised Intra-Cellular's price target to $37 from $35, saying the FDA NDA acceptance "meaningfully" de-risked the potential for lead drug lumateperone in its most advanced indication, schizophrenia. The analyst also believe shares significantly undervalue lumateperone's potential across neuropsych indications, with potential for bipolar depression data and schizophrenia approval to catalyze upside in 2019. He keeps an Outperform rating on the stock.
05/23/19
CANT
05/23/19
NO CHANGE
Target $29
CANT
Overweight
Intra-Cellular price target raised to $29 from $26 at Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan raised his price target for Intra-Cellular to $29 from $26 and reiterates an Overweight rating on the shares. Following due diligence, the analyst sees reduced regulatory and commercial risk for lumateperone in its lead indication schizophrenia.

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