Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.
Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur well for the ongoing, late-stage program with the compound as an adjunctive treatment in MDD.
With phase III data due from Karuna Therapeutics Inc. with its combo Karxt therapy for schizophrenia, interest is rising in the historically difficult space. Karxt pairs xanomeline, a muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, with trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.