FDA provides path forward for Prosensa DMD drug drisapersen
This article was originally published in Scrip
Executive Summary
Investors rallied around shares of Dutch biotech Prosensa in premarket trading on 3 June on word the FDA had provided a way forward for the company to file a new drug application (NDA) under an accelerated approval pathway for its experimental Duchenne muscular dystrophy (DMD) drug drisapersen, although with a tone of skepticism.