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Why Egalet's FDA PDUFA Delay Is No Cause For Panic

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Why Egalet's FDA PDUFA Delay Is No Cause For Panic

Shares of Egalet Corp (NASDAQ: EGLT) traded lower by more than 5 percent Monday morning after a scheduled meeting with the U.S. Food and Drug Administration (FDA) to discuss its delayed ARYMO ER therapy.

Egalet said in a press release that the FDA "has identified no particular issue with our application for ARYMO ER and that the Agency is working on the product label." The company added, "The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application."

Related Link: Exclusive: Egalet CFO Talks 'Hot Button' Rx Abuse-Deterrence, Pipeline And Multimillion-Dollar Financing

Chiara Russo of Cantor Fitzgerald defended Egalet in a research report, noting that the delay is likely " temporary and fits into an emerging pattern around opioid drug submissions that ultimately leads to an approval."

The analyst added that while the FDA's delay is "not ideal," the ongoing pressure and attention around opioid abuse represents a "complex and scrutinous" situation for the agency.

Russo continued that if the FDA delays its approval to late November, then this "does not rattle or model" and the company's access to financing won't be "in any serious jeopardy."

"We maintain our belief that EGLT has demonstrated best-in-class abuse-deterrence technology which will be reflected on final product labeling," Russo argued.

Shares of Egalet were reiterated with a Buy rating and unchanged $21 price target.

At last check, however, Egalet was up 5.04 percent at $7.50.

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Latest Ratings for EGLT

DateFirmActionFromTo
Aug 2018JMP SecuritiesMaintainsMarket OutperformMarket Outperform
Mar 2018Cantor FitzgeraldMaintainsOverweightOverweight
Jan 2018Stifel NicolausDowngradesBuyHold

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