FDA wants more Bexxar studies

Corixa (CRXA) received a complete review letter from the FDA for its Bexxar NHL radioimmunotherapy in which the agency said additional clinical studies would be required to show evidence of safety and net clinical benefit. CRXA, which acquired Bexxar tositumomab through its 2000 acquisition of Coulter (South San Francisco, Calif.), was off $3.48 (36%) to $6.15 on 9.2 million shares on Wednesday.

CRXA said the FDA letter said the company has 10 days to amend the Bexxar application, notify the agency of its intent to amend the application, withdraw the filing or request a hearing. CRXA said it will request a meeting with FDA, which the company expects to occur within 45 days. ...