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Monday, April 8, 2019

Zogenix hit after FDA rejects filing

Zogenix Inc. ZGNX, -0.29% shares dropped in the extended session Monday after announcing that the Food and Drug Administration did not accept a marketing application for one of its drugs. Following a brief halt, Zogenix shares fell 25% after hours, following a 0.3% decline to close at $51.85 in the regular session. The developer of rare-disease therapies said the FDA rejected a marketing application for its drug Fintelpa to treat seizures from Dravet syndrome because they were “not sufficiently complete to permit a substantive review.” Zogenix said it would seek immediate guidance from the FDA to respond to issues raised in the rejection.

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