Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe


Intra-Cellular Shares Soar on Positive Bipolar Depression Study Findings

Share on Stocktwits


Shares of Intra-Cellular Therapies traded 77% higher after the company reported that positive data from its Phase 3 Study 402 will form the basis for its sNDA for lumateperone in treating bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy.

This morning biopharmaceutical company Intra-Cellular Therapies Inc. (ITCI:NASDAQ), which is focused on the development of therapeutics for central nervous system (CNS) disorders, announced "positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder."

The firm stated that in the Phase 3 Study 402, once daily lumateperone 42 mg successfully achieved the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score, and it additionally met the study's secondary endpoint, the CGI-BP-S Depression Score. The company indicated that lumateperone demonstrated a favorable safety profile and was generally well tolerated in the trial.

The company noted that the data from this trial together with the results of its previously reported positive Phase 3 monotherapy study, Study 404, will form the basis for its Supplemental New Drug Application (sNDA) for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. The firm advised that it expects that it will submit the sNDA to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.

The company's Chair and CEO Dr. Sharon Mates commented, "Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone's label to include a second major neuropsychiatric disorder...With this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia."

Dr. Roger McIntyre, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, remarked, "Bipolar disorders are serious and complex mental health conditions that affect millions of people, and depression is the most common presentation of these disorders. In this study, lumateperone demonstrated a robust effect, which is particularly significant considering patients were maintained on lithium or valproate...Lumateperone is the first treatment to demonstrate efficacy for bipolar depression as monotherapy and as adjunctive therapy to mood stabilizers in a study population including both Bipolar I and Bipolar II patients. This will be welcome news to the psychiatric community as there is a tremendous need for improved treatment options."

The company noted that its Phase 3 Study 402 took place in the U.S. and four other countries and included 529 patients with moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder. Patients in the study were maintained on lithium or valproate as mood stabilizers and were randomized equally to either lumateperone 42 mg, 28 mg or placebo. The firm noted that the results showed that 42 mg dose of lumateperone met both the primary and secondary endpoints versus placebo at week 6 measured by change from baseline on the MADRS total score and the improvement on the CGI-BP-S Depression Score. Lumateperone 28 mg also displayed a trend for a dose-related improvement in symptoms of depression, but it was not formally tested against placebo though it did demonstrate a statistically significant improvement versus placebo on the CGI-BP-S Depression Score.

The company explained that "pharmacodynamics studies have shown lumateperone acts as a potent antagonist with high binding affinity at serotonin 5-HT2A receptors." The firm added that "these receptors are believed to play an important role in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders."

The company stated that lumateperone is presently being investigated for use in the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders, but has not yet been approved by FDA for these disorders. The firm's CAPLYTA 42 mg (lumateperone) has already been approved by the FDA for use in treatment of adult schizophrenia.

The firm explained that Bipolar I and Bipolar II disorders are highly prevalent serious psychiatric conditions that effect approximately 6 million adults in the U.S. Bipolar I & II disorders occur nearly equally in patients suffering with bipolar disorders with symptoms that typically include recurrent episodes of mania or hypomania intermixed with episodes of serious depression, which is commonly referred to as Bipolar depression. The company advised that Bipolar depression episodes usually tend to recur more often, last longer and are associated with a worse prognosis than the manic or hypomanic episodes.

Intra-Cellular Therapies is a biopharmaceutical company headquartered in New York that focuses on understanding of how therapies affect the inner-workings of cells in the body. The company states it employs this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases to help reduce the burden on patients and their caregivers.

Intra-Cellular Therapies started the day with a market capitalization of around $1.2 billion with approximately 67.31 million shares outstanding and a short interest of about 7.4%. ITCI shares opened nearly 70% higher today at $31.10 (+$12.67, +68.75%) over yesterday's $18.43 closing price. The stock has traded today between $27.87 and $33.74 per share and is currently trading at $32.57 (+$14.14, +76.72%).


1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe