Security market reaction to FDA fast track designations.

Abstract

Pharmaceutical firms can apply for the Food and Drug Administration to 'fast track' research and de velopment on new drugs, accelerating clinical trials and expediting regulatory review required prior to marketing to consumers. We investigate security market reaction to more than 100 fast track designations from 1998 to 2004. Fast track designation appears to enhance investor recognition of firm value. Specifically, fast track designation coincides with abnormal trading volume and excess daily stock returns for sponsoring firms. Institutional ownership and analyst attention also increase. Market response is more pronounced for firms that are smaller, do not yet market products, and have low institutional ownership.