Zogenix (ZGNX) Surges Despite PDUFA Delay; Analysts View Positively

February 27, 2013 10:13 AM EST
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Zogenix, Inc. (NASDAQ: ZGNX) sees sharp upside despite a FDA PDUFA delay on Zohydro.

After the close, Zogenix said it been informed by the FDA that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013.

Analysts view the news as a potential positive.

Wells Fargo analyst Michael Tong comments: "FDA to miss Zohydro ERs’ 3/1/2013 PDUFA date, but the delay is likely short (weeks). We continue to believe the odds for eventual approval are high. We speculate FDA is dealing with issues of access and potential misuse. At the current valuation, we view the reward/risk profile of ZGNX shares as skewed toward the reward side. We see 20% downside potential on a negative FDA decision but potentially 100%+ upside on a positive decision." The firm maintained an Outperform and $3.50-$4.00 price target.

Shares of ZGNX are up 46 percent.

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