The U.S. Food and Drug Administration issued a Complete Response Letter to Chicago’s Levo Therapeutics for the company’s New Drug Application for LV-101, which is being developed as a treatment for hyperphagia (excessive overeating), anxiousness and distress associated with Prader-Willi syndrome (PWS).
Zafgen Inc said the U.S. Food and Drug Administration was putting a late-stage study testing its experimental obesity drug on complete hold after a second patient died during the trial. The company’s shares fell 7.4 percent to $5.81 in extended trading after closing down 60 percent on Wednesday. A complete clinical hold is an order […]
A second patient died in a late-stage trial of Zafgen Inc’s experimental obesity treatment, highlighting safety concerns associated with drugs that aim to treat a condition that affects one in three Americans. Shares of Zafgen tumbled more than 50 percent to $8.00 in premarket trading on Wednesday. The company said a patient receiving its drug, […]