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FDA Grants Approval for CNS-Focused Biopharma Firm's Bipolar Disorder Drug
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Intra-Cellular Therapies Inc. shares traded 19% higher to a new 52-week high after the company reported the U.S. FDA has approved the use of its CAPLYTA® (lumateperone) for treatment of adults with bipolar depression.


This morning before U.S. markets opened, biopharmaceutical company Intra-Cellular Therapies Inc. (ITCI:NASDAQ), which is engaged in developing therapeutics for central nervous system (CNS) disorders, announced that "the U.S. Food and Drug Administration (FDA) approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate."

The company's Chairman and CEO Dr. Sharon Mates commented, "CAPLYTA is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. CAPLYTA has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances). We are positioned to launch immediately and are excited to offer CAPLYTA to the millions of patients living with bipolar depression."

The company advised that bipolar I and bipolar II disorder are serious chronic psychiatric conditions that effect about 11 million adults in the U.S. The firm explained that bipolar depression is the most frequently observed symptom presented due to bipolar disorder. The firm stated that the depressive episodes affected individuals experience typically occur more often and last longer than manic episodes.

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, Canada remarked, "The efficacy, and favorable safety and tolerability profile, make CAPLYTA an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients. CAPLYTA is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options."

The report stated that the FDA approved CAPLYTA's for these new indications based upon the results obtained during two positive Phase 3 bipolar depression studies. One of the placebo-controlled studies was structured to evaluate the efficacy and effects of CAPLYTA on depression in adult patients with bipolar I or bipolar II disorder as monotherapy and the other as an adjunctive therapy with lithium or valproate.

The company indicated that data collected in these trials showed that at week six, CAPLYTA 42 mg achieved statistically significant improvements over placebo for the change from baseline in the Montgomery-Asberg Depression Rating scale (MADRS) total score. In addition, CAPLYTA 42 mg also delivered statistically significant improvement in clinical global impression of bipolar disorder, a key secondary endpoint in each of the studies.

The firm listed that CAPLYTA (lumateperone) 42 mg is "an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate."

The company mentioned that the FDA has authorized its CAPLYTA 42 mg (lumateperone) for use in adult schizophrenia treatment. Lumateperone is currently also now being evaluated as a potential treatment for major depressive disorder along with other neuropsychiatric and neurological disorders, though the FDA has not yet approved lumateperone for addressing these disorders.

Intra-Cellular Therapies is a biopharmaceutical company based in New York, N.Y. that focuses on understanding of how therapies affect the inner workings of cells in the body. The company uses an intracellular approach to develop new treatments for people diagnosed with complex psychiatric and neurologic diseases in order to help reduce the burden on patients and their caregivers.

Intra-Cellular Therapies began the day with a market cap of around $3.2 billion with approximately 81.46 million shares outstanding and a short interest of about 4.4%. ITCI shares opened 12% higher today at $43.86 (+$4.70, +12.00%) over Friday's $39.16 closing price and reached a new 52-week high price this morning of $49.00. The stock has traded today between $42.42 and $49.00 per share and is currently trading at $46.65 (+$7.49, +19.13%).


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