Shares of Intra-Cellular Therapies Inc. (ITCI) have popped more than 20%, or $3.82, to $22.79 in premarket trading Thursday, Sept. 7 after the company reported positive topline data in an early study of schizophrenia patients who were switched from standard-of-care antipsychotic medications to the company's lumateperone. Intra- Cellular hopes to market the drug as one with fewer side effects than currently available antipsychotic treatments, which frequently cause motor side effects and/or weight gain, cardiovascular complications, dyslipidemia, and hyperglycemia.Intra-Cellular said the study showed patients switched to statistically significant improvements in body weight, cardiometabolic and endocrine parameters in patients when switched to lumateperone. The systems reverted when patients switched back to previous medications.
Alnylam Pharmaceuticals Inc. (ALNY) has suspended patient trials of its hemophilia drug fitusiran after a patient died while undergoing treatment. Shares of the company were down more than 10% premarket Thursday, dropping $9.02 to $77.00. The company said dosing will be halted in all ongoing fitusiran studies pending further review and development of a risk mitigation strategy. Nevertheless, the company said based on overall consideration of fitusiran's benefit-risk profile, Alnylam "aims to resume dosing as soon as possible upon agreement with global regulatory authorities and with appropriate protocol amendments in place for enhanced patient safety monitoring."