Fly News Breaks for February 27, 2020
Feb 27, 2020 | 09:58 EDT
Stifel analyst Paul Matteis was initially "surprised" that the PDUFA for Fintepla in Dravet Syndrome was extended. That said, after catching up with management, he feels "considerably better," and reiterates a Buy rating on Zogenix's stock. During his discussion with Zogenix, the analyst learned that the major amendment was related to additional analyses of efficacy and not safety related, Zogenix already provided FDA with a substantial safety update at Day 120 and does not believe more safety data will be required, there's been zero indication from FDA that there will be an adcomm, and management is still very confident in approval.
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