Introduction and summary of investment thesis for Zogenix:
I have been following Zogenix (ZGNX) for more than two years and had a >300% return since my initiation article (in 2017) after the company’s excellent data for its low dose fenfluramine formulation, ZX008 in treating refractory seizures due to Dravet’s syndrome. FDA issued a refuse to file letter for the company's application to approve ZG008 in treating refractory seizures due to Dravet’s syndrome recently, resulting in a fall in the stock price.
The specific issues raised by FDA were:
- Certain non-clinical studies were not