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ITCI

Intra-Cellular

$13.44

0.58 (4.51%)

07:04
07/08/19
07/08
07:04
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07:04

Intra-Cellular announces Study 404 of lumateperone met primary endpoint

Intra-Cellular Therapies announced 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. In Study 404, lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score. Study 404 also met its key secondary endpoint, Clinical Global Impression Scale for Bipolar for Severity of Illness Total Score. In both trials, lumateperone demonstrated a favorable safety profile and was generally well-tolerated. Study 404 was conducted globally including in the U.S. A total of 381 patients were randomized 1:1 to lumateperone 42 mg or placebo. In this trial, once-daily lumateperone 42 mg met the primary endpoint with statistically significant greater improvement over placebo at week 6 as measured by change from baseline on the MADRS total score. In the intent-to-treat study population, the least squares mean reduction from baseline for lumateperone 42 mg was 16.7 points, versus 12.1 points for placebo. Moreover, lumateperone 42 mg showed statistically significant separation from placebo as early as week 1, which was maintained at every time point throughout the trial. Lumateperone 42 mg also met the key secondary endpoint of statistically significant improvement on the CGI-BP-S Total Score and on the CGI component that specifically assesses depression. These results were supported by statistically significant benefits on responder rates and remission rates, demonstrating the clinical meaningfulness of the primary outcome. In addition, in subgroup analyses of patients with Bipolar I and patients with Bipolar II disorder lumateperone 42 mg demonstrated statistically significant improvement versus placebo on the MADRS total score in both subgroups. 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. Consistent with previous studies in schizophrenia, lumateperone was well-tolerated in both bipolar depression studies, with a favorable safety profile. The rates of discontinuation due to treatment emergent adverse events for both doses of lumateperone were low. In Study 404, the most commonly reported adverse events that were observed at a rate greater than 5% and higher than placebo were headache, somnolence and nausea. In Study 401, the most commonly reported adverse events that were observed at rates greater than 5% and higher than placebo for either dose were somnolence, headache, nausea, dry mouth, dizziness, diarrhea, vomiting and fatigue. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo in both studies. These findings are consistent with previous lumateperone trials in patients with schizophrenia and provide further evidence supporting lumateperone's favorable safety and tolerability profile across different patient populations.

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ITCI Intra-Cellular
$13.44

0.58 (4.51%)

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.
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.
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.
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.

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