Cortex has inactivated but hasn't formerly withdrawn the IND while it reviews the FDA response but said any resubmission for ADHD is unlikely. The company is also studying CX717 for acute treatment of respiratory depression and for Alzheimer's Disease. Cortex noted that an acute indication requiring a lower dose or an indication with a different risk/benefit profile would be a better fit for the drug. Shares tumbled $1.14, or 63%, to 66 cents. On the rising side, Novacea ( NOVC) edged up 11 cents, or 1.7%, to $8.60, after initiating a phase II, 56-patient trial for banoxantrone, an investigational anti-cancer prodrug in patients with relapsed or refractory acute lymphoblastic leukemia (ALL), a type of cancer that starts with white blood cells in the bone marrow. The primary efficacy objective is the response rate over three cycles of the drug, and the secondary efficacy objectives are duration of response and overall survival. The study will also evaluate safety and tolerability. Also, Momenta ( MNTA) climbed after disclosing top-line results from a phase I study and announcing that it treated the first patient in its phase II study (called the Eminence trial) on the IV formulation of its blood thinner M118. The study is designed to treat patients with stable coronary artery disease who are undergoing percutaneous coronary intervention (PCI). Shares rose 63 cents, or 5%, to $13.08.
Stocks soar as the gross domestic product rises at an annualized rate of 3.5% in the third quarter and continuing jobless claims fall. Gregg Greenberg recaps the action in The Real Story video (above).