Fintepla RTF resolution a win for Zogenix, says Stifel
Stifel analyst Paul Matteis says Fintepla RTF resolution is a win for Zogenix and in line with the best-case scenario in terms of time-to-resubmission of the NDA. The analyst adds that the outcome reinforces his longstanding view that the RTF did not imply the existence an actual unknown approvability issue within the Fintepla clinical dataset. While Matteis acknowledges that the loss of Breakthrough Designation is a surprise, he does not think this negatively impacts Fintepla approvability, and believes that rescinding BTD is more of an administrative outcome linked to the lack of head-to-head data versus Epidiolex and the fact that Zogenix did not include any CBD-treated patients in its Phase 3 studies. The analyst has a Buy rating on the shares.