Zogenix agreement with FDA 'best case scenario,' says Piper Jaffray
The FDA, in a "surprise turn of events," indicated that it agreed with Zogenix's plan to re-submit their Fintepla new drug application without generating new preclinical toxicity data, Piper Jaffray analyst Danielle Brill tells investors in a research note. Although breakthrough therapy status was rescinded due to the recent approvals of two other drugs for Dravet Syndrome, Brill still expects an expedited review and she estimates approval and launch by Q2 of 2020. The analyst views the news as the "best case scenario" for Zogenix. She does not expect the delay to have any meaningful impact on Fintepla's overall commercial potential and reiterates an Overweight rating on the shares with a $64 price target. The stock in afternoon trading is up 21%, or $8.24, to $47.65.