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Fly News Breaks for April 9, 2019
ZGNX
Apr 9, 2019 | 09:00 EDT
SVB Leerink analyst Marc Goodman lowered his price target for Zogenix to $48 from $60 after the company received a Refusal to File letter from the FDA regarding the NDA filing for Fintepla in Dravet syndrome. The analyst notes that the FDA decision was based on two reasons, namely certain non-clinical studies that were not submitted, and an incorrect version of a clinical data set that was submitted. This is "clearly disappointing news," he contends, suggesting that management made a clear error in regard to what the FDA wanted in the filing. Goodman reiterates an Outperform rating on the shares.
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