Intra-Cellular Therapies, Inc. (ITCI) stock surged 18.77% in the pre-market trading session at the price of $46.51 following the FDA approval of CAPLYTA.
ITCI is a biopharmaceutical firm established on Nobel prize-winning research that provides insights into how therapies impact the inner working of body cells. The company leverages this intracellular approach to present novel treatments for patients living with complex neurologic diseases.
ICTI Announced FDA-Approval for CAPLYTA
On 20th December 2021, ITCI reported that FDA had approved CAPLYTA to treat depressive episodes related to bipolar I or II disorder in adults. The approval for CAPLYTA’s indications had based on two positive placebo-controlled Phase 3 bipolar depression studies. The clinical studies evaluated the results of CAPLYTA on depression in adults with bipolar I or II disorder. Additionally, CAPLYTA demonstrated high tolerability and a safety profile compatible with findings in previous clinical studies in schizophrenia.
Chairman and Chief executive officer of ITCI, Dr. Sharon Mates, remarked that CAPLYTA is the only FDA-approved medicine that treats depressive disorders related to bipolar I or II disorders. CAPLYTA has shown an invariably promising profile on weight, extrapyramidal symptoms, and cardiometabolic parameters. They are well-positioned to launch and deliver CAPLYTA to the millions of patients dealing with bipolar depression. He thanked the patients, healthcare specialists, and the management team for their contributions that had supported this approval.
Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Dr. Roger McIntyre, commented that the efficacy, safety, and tolerability profile had made CAPLYTA an effective treatment for patients with bipolar I or II depression. CAPLYTA had also approved for those patients with bipolar II depression who have been underserved with limited treatment options.
Demise of Director, Dr. Richard Lerner
On 6th December 2021, ITCI mourned the demise of one of its Directors, Richard Lerner. He contributed numerous research discoveries that have had widespread impacts on science and medicine. He has served as a scientific leader on the company’s board of directors since its formation in 2002. Dr. Lerner has earlier worked as President of the Scripps Research Institute for over 25 years.