New York-based Intra-Cellular Therapies published the results of the company’s Study 404 phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
Sage Therapeutics ended two late-stage studies of the depression drug zuranolone after discussions with the U.S. Food and Drug Administration led the company to believe they were unnecessary for potential regulatory approval.
Alkermes Plc said on June 1 the U.S. Food and Drug Administration approved the company’s Lybalvi for the treatment of schizophrenia and bipolar I disorder.
Several biopharmaceutical companies submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease.
The U.S. Food and Drug Administration issued a Complete Response Letter for Alkermes’ New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar 1 disorder, and a CRL for Adamis Pharmaceuticals’ NDA for the high-dose naloxone injection product ZIMHI for the treatment of opioid overdose.
A Paris-based prosecutor initiated an investigation into Sanofi over the company’s drug Depakine, which is on the market for epilepsy and bipolar disorder.
Intra-Cellular Therapies Inc.’s lead drug failed to meet the main goal of a late-stage study in patients with major depressive episodes associated with bipolar disorder.
Allergan Plc’s Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, expanding the scope of treatment to a full spectrum of symptoms related to the condition.
Denmark’s H. Lundbeck and Japan’s Otsuka Pharmaceutical announced that the antipsychotic drug Rexulti (brexpiprazole) failed to meet the primary endpoint in two Phase III clinical studies to treat manic episodes in patients with bipolar I disorder.
Seattle-based Impel NeuroPharma closed on a Series D financing totaling $67.5 million, co-led by KKR and Northwest Venture Partners.