Regulatory Milestones

Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) gained $0.09 (18%) to $0.63 last week after FDA issued a complete response letter for an NDA for Pixuvri pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). The agency requested an additional clinical trial to demonstrate safety and efficacy (see B7).

Forest Laboratories Inc. (NYSE:FRX) was off $3.18 (10%) to $28.25 last week after FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-5 that safety and efficacy data do not provide enough evidence to support the approval of Daxas roflumilast for chronic obstructive pulmonary disease (COPD). Forest has U.S. rights from Nycomed (see Cover Story)...